From 9bf0797c8bb2b6fb9794527fbb423d59597aed16 Mon Sep 17 00:00:00 2001 From: Quarto GHA Workflow Runner Date: Fri, 7 Jun 2024 23:42:46 +0000 Subject: [PATCH] Built site for gh-pages --- .nojekyll | 2 +- about.html | 2 +- dev_background.html | 2 +- faq.html | 2 +- index.html | 2 +- listings.json | 1 + minutes.html | 97 ++-- minutes.xml | 234 +++++---- minutes/2020-12-04/index.html | 2 +- minutes/2021-01-15/index.html | 2 +- minutes/2021-02-05/index.html | 2 +- minutes/2021-03-05/index.html | 2 +- minutes/2021-04-05/index.html | 2 +- minutes/2021-05-07/index.html | 2 +- minutes/2021-06-04/index.html | 2 +- minutes/2021-08-06/index.html | 2 +- minutes/2021-09-03/index.html | 2 +- minutes/2021-10-01/index.html | 2 +- minutes/2021-11-05/index.html | 2 +- minutes/2021-12-03/index.html | 2 +- minutes/2022-01-07/index.html | 2 +- minutes/2022-02-04/index.html | 2 +- minutes/2022-03-05/index.html | 2 +- minutes/2022-04-01/index.html | 2 +- minutes/2022-05-06/index.html | 2 +- minutes/2022-06-04/index.html | 2 +- minutes/2022-07-01/index.html | 2 +- minutes/2022-08-05/index.html | 2 +- minutes/2022-09-02/index.html | 2 +- minutes/2022-10-07/index.html | 2 +- minutes/2022-11-04/index.html | 2 +- minutes/2022-12-02/index.html | 2 +- minutes/2023-01-13/index.html | 2 +- minutes/2023-02-03/index.html | 2 +- minutes/2023-03-03/index.html | 2 +- minutes/2023-04-07/index.html | 2 +- minutes/2023-05-05/index.html | 2 +- minutes/2023-06-02/index.html | 2 +- minutes/2023-07-07/index.html | 2 +- minutes/2023-08-04/index.html | 2 +- minutes/2023-09-01/index.html | 2 +- minutes/2023-10-06/index.html | 2 +- minutes/2023-11-03/index.html | 2 +- minutes/2023-12-01/index.html | 2 +- minutes/2024-01-05/index.html | 2 +- minutes/2024-02-02/index.html | 2 +- minutes/2024-03-01/index.html | 2 +- minutes/2024-04-05/Index.html | 2 +- minutes/2024-05-03/index.html | 2 +- minutes/2024-06-07/ADRG.png | Bin 0 -> 186154 bytes minutes/2024-06-07/dates.png | Bin 0 -> 199954 bytes minutes/2024-06-07/index.html | 897 ++++++++++++++++++++++++++++++++++ minutes_prep.html | 2 +- pilot1.html | 2 +- pilot2.html | 2 +- pilot3.html | 2 +- pilot4.html | 2 +- pilot_background.html | 2 +- search.json | 796 ++++++++++++++++-------------- sitemap.xml | 178 +++---- 60 files changed, 1657 insertions(+), 650 deletions(-) create mode 100644 minutes/2024-06-07/ADRG.png create mode 100644 minutes/2024-06-07/dates.png create mode 100644 minutes/2024-06-07/index.html diff --git a/.nojekyll b/.nojekyll index 22fa0cf..aebd462 100644 --- a/.nojekyll +++ b/.nojekyll @@ -1 +1 @@ -3c963940 \ No newline at end of file +a2e4b0cc \ No newline at end of file diff --git a/about.html b/about.html index ec32079..ae910d1 100644 --- a/about.html +++ b/about.html @@ -2,7 +2,7 @@ - + diff --git a/dev_background.html b/dev_background.html index 828df74..96e8c55 100644 --- a/dev_background.html +++ b/dev_background.html @@ -2,7 +2,7 @@ - + diff --git a/faq.html b/faq.html index 92aed19..a9e9c17 100644 --- a/faq.html +++ b/faq.html @@ -2,7 +2,7 @@ - + diff --git a/index.html b/index.html index 9150eb3..7ae016d 100644 --- a/index.html +++ b/index.html @@ -2,7 +2,7 @@ - + diff --git a/listings.json b/listings.json index 3ac7c2a..fbbc62c 100644 --- a/listings.json +++ b/listings.json @@ -2,6 +2,7 @@ { "listing": "/minutes.html", "items": [ + "/minutes/2024-06-07/index.html", "/minutes/2024-05-03/index.html", "/minutes/2024-04-05/Index.html", "/minutes/2024-03-01/index.html", diff --git a/minutes.html b/minutes.html index 76c38b5..b28d9c8 100644 --- a/minutes.html +++ b/minutes.html @@ -2,7 +2,7 @@ - + @@ -222,7 +222,7 @@ +
Categories
All (42)
@@ -290,7 +290,18 @@

Meeting Minutes

- + + +Jun 7, 2024 + + +Minutes 2024-06-07 + + +Joseph Rickert + + + May 3, 2024 @@ -301,7 +312,7 @@

Meeting Minutes

Joseph Rickert - + Apr 5, 2024 @@ -312,7 +323,7 @@

Meeting Minutes

Joseph Rickert - + Mar 1, 2024 @@ -323,7 +334,7 @@

Meeting Minutes

Joseph Rickert - + Feb 2, 2024 @@ -334,7 +345,7 @@

Meeting Minutes

Joseph Rickert - + Jan 5, 2024 @@ -345,7 +356,7 @@

Meeting Minutes

Joseph Rickert - + Dec 1, 2023 @@ -356,7 +367,7 @@

Meeting Minutes

Joseph Rickert - + Nov 3, 2023 @@ -367,7 +378,7 @@

Meeting Minutes

Joseph Rickert - + Oct 6, 2023 @@ -378,7 +389,7 @@

Meeting Minutes

Joseph Rickert - + Sep 1, 2023 @@ -389,7 +400,7 @@

Meeting Minutes

Joseph Rickert - + Aug 4, 2023 @@ -400,7 +411,7 @@

Meeting Minutes

Joseph Rickert - + Jul 7, 2023 @@ -411,7 +422,7 @@

Meeting Minutes

Joseph Rickert - + Jun 2, 2023 @@ -422,7 +433,7 @@

Meeting Minutes

Joseph Rickert - + May 5, 2023 @@ -433,7 +444,7 @@

Meeting Minutes

Joseph Rickert - + Apr 7, 2023 @@ -444,7 +455,7 @@

Meeting Minutes

Joseph Rickert - + Mar 3, 2023 @@ -455,7 +466,7 @@

Meeting Minutes

Joseph Rickert - + Feb 9, 2023 @@ -466,7 +477,7 @@

Meeting Minutes

Joseph Rickert - + Jan 13, 2023 @@ -477,7 +488,7 @@

Meeting Minutes

Eric Nantz - + Dec 2, 2022 @@ -488,7 +499,7 @@

Meeting Minutes

Joseph Rickert - + Nov 4, 2022 @@ -499,7 +510,7 @@

Meeting Minutes

Joseph Rickert - + Oct 7, 2022 @@ -510,7 +521,7 @@

Meeting Minutes

Joseph Rickert - + Sep 2, 2022 @@ -521,7 +532,7 @@

Meeting Minutes

Joseph Rickert - + Aug 5, 2022 @@ -532,7 +543,7 @@

Meeting Minutes

Joseph Rickert - + Jul 1, 2022 @@ -543,7 +554,7 @@

Meeting Minutes

Joseph Rickert - + Jun 4, 2022 @@ -554,7 +565,7 @@

Meeting Minutes

Joseph Rickert - + May 6, 2022 @@ -565,7 +576,7 @@

Meeting Minutes

Joseph Rickert - + Mar 4, 2022 @@ -576,7 +587,7 @@

Meeting Minutes

Joseph Rickert - + Feb 4, 2022 @@ -587,7 +598,7 @@

Meeting Minutes

Joseph Rickert - + Jan 7, 2022 @@ -598,7 +609,7 @@

Meeting Minutes

Joseph Rickert - + Dec 3, 2021 @@ -609,7 +620,7 @@

Meeting Minutes

Joseph Rickert - + Dec 3, 2021 @@ -620,7 +631,7 @@

Meeting Minutes

Joseph Rickert - + Nov 5, 2021 @@ -631,7 +642,7 @@

Meeting Minutes

Joseph Rickert - + Oct 1, 2021 @@ -642,7 +653,7 @@

Meeting Minutes

Joseph Rickert - + Sep 3, 2021 @@ -653,7 +664,7 @@

Meeting Minutes

Joseph Rickert - + Aug 6, 2021 @@ -664,7 +675,7 @@

Meeting Minutes

Joseph Rickert - + Jun 4, 2021 @@ -675,7 +686,7 @@

Meeting Minutes

Joseph Rickert - + May 7, 2021 @@ -686,7 +697,7 @@

Meeting Minutes

Joseph Rickert - + Apr 5, 2021 @@ -697,7 +708,7 @@

Meeting Minutes

Joseph Rickert - + Mar 5, 2021 @@ -708,7 +719,7 @@

Meeting Minutes

Joseph Rickert - + Feb 5, 2021 @@ -719,7 +730,7 @@

Meeting Minutes

Joseph Rickert - + Jan 15, 2021 @@ -730,7 +741,7 @@

Meeting Minutes

Joseph Rickert - + Dec 4, 2020 diff --git a/minutes.xml b/minutes.xml index a547a75..4a7a6fc 100644 --- a/minutes.xml +++ b/minutes.xml @@ -9,8 +9,142 @@ https://rconsortium.github.io/submissions-wg/minutes.html -quarto-1.4.554 -Fri, 03 May 2024 00:00:00 GMT +quarto-1.4.555 +Fri, 07 Jun 2024 00:00:00 GMT + + Minutes 2024-06-07 + Joseph Rickert + https://rconsortium.github.io/submissions-wg/minutes/2024-06-07/ + + +
+
+
    +
  • Ben Straub (GSK)
    • +
  • Eva Li
    • +
  • Heidi Curinckx (Johnson & Johnson)
    • +
  • HyeSoo Cho (FDA)
    • +
  • Ismael Alejandro Rodriguez (Appsilon)
    • +
  • Jane Owens (Phuse & Eli Lilly)
    • +
  • Joel Laxamana (Roche/Genentech)
    • +
  • Joseph Rickert (R Consortium)
    • +
  • Lovemore Gakava (Novo Nordisk)
    • +
  • Ning Leng (Roche/Genentech)
    • +
  • Paul Schuette (FDA)
    • +
  • Saghir Bashir (Argenx)
    • +
  • Stephanie Lussier (Moderna)
    • +
  • Steven Hasendinckx (Johnson & Johnson)
    • +
  • YounKyeong Chang (FDA)
    • +
+
+
+ +

The meeting was recorded and the video is available.

+
+

PharmaSUG Conference

+
    +
  • Both Ben Straub (Pilot 3) and Ismael Rodriguez (Pilot 4) gave talks at the recent Pharma SUG conference which was held in Baltimore.
    • +
  • Both reported that there was a lot of interest in their talks
    • +
  • Ben reported that he spoke to several people who thought the the FDA only approves SAS submissions.
    • +
  • Both presentations will be placed in the R Submissions WG GitHub repository.
    • +
+
+
+

Coordination with R Package Validation

+
    +
  • Ismael noted that Magnus from a package validation working group approached him about cooperating with the Submissions WG.
    • +
  • JBR asked Ismael to ask Magnus to write to him and said that we be happy to invite Magnus to our meetings.
    • +
+
+
+

Pilot 3

+

Hye Soo Cho and YounKyeong Chang provided an update on their review of the Pilot 3 submission.

+
    +
  • The FDA eviewers are wrapping up their review.
    • +
  • There are no major issues.
    • +
  • They were able to install the Util package from the zip file and review the R programs to drive the ADaM data sets.
    • +
  • QC of the ADRG did turn up a minor issue regarding inconsistencies among three date variables. +
      +
    • The discussion of this issue begins at 7:55 in the video and is illustrated in the screen capture below.
      • +
    • The recommended solution is that the date origin should be specified in ISO 8601 date/time format in the ADRG.
      • +
    • Joel agreed to review the record of issues with Pilot 3 and see if there are any other parameters that ought to be explicitly mentioned in the ADRG.
      • +
    • +
+

+
+
+

Pilot 4

+

Eric Nantz described progress on the Pilot 4 Submission.

+
    +
  • The end of June is still our target for the WebAssembly version of Pilot 4.
    • +
  • The plan is to do the container version at a later time after the WebAssembly version has been reviewed.
    • +
  • The question was asked if there are any special rules about package downloads.
    • +
  • Paul Schuette stated that downloading from CRAN is preferable, that in addition to the serialization FDA Security has mentioned downloads as a potential security problem, but that as far as he knows there are no regulations.
    • +
  • Eric pointed out that the Docker version of Pilot 4 also requires an image download.
    • +
  • Eric and Paul will meet to discuss this issue.
    • +
  • Eric will provide ADRG instructions and he and Paul will investigate,
    • +
  • Paul noted that the FDA has recently approved WSL (Windows System Linux)
    • +
+
+
+

ADRG

+

There has been discussion within the working group as to whether we should investigate best practices for writing ADRGs for R based submissions. JBR noted that recent comments in issue #112 suggested that we should coordinated with the PHUSE ADRG working group. Discussion begins at 29:00 into the video.

+
    +
  • As it turned out Jane Owens (Eli Lilly) who is co-lead of the PHUSE ADRG working group was on the call.
    • +
  • PHUSE owns the ADRG templates
    • +
  • They are actively working on updating the templates with respect to R in section 7.1 of the template.
    • +
  • Pilot 3 has documentation on R packages in Section 7 and in an appendix to the ADRG (Section 9).
    • +
+

+
    +
  • PHUSE got its starting point for updating the ADRG for R from J&J which Heidi Curinckx confirmed is based on J&J’s participation in the Submissions WG.
    • +
  • The PHUSE WG will publish their updated template and then send it out for review
    • +
  • The Submissions WG and the PHUSE ADRG WG will cooperate and share information.
    • +
  • JBR invited Jane and other members of her WG to attend future meetings.
    • +
+
+
+

R Versions Blog Post

+

A small group led my Ning Leng is working on a blog post aimed at generating consensus about what versions of R might be appropriate for R based submissions at any point in time.

+
    +
  • The post has been revised to reelect the Submissions WG point of view and ends with a request for readers to comment in an issue that that we will open up on our GitHub repository.
    • +
  • The post includes paragraphs on how four companies Roche, Lilly, GSK, Pfizer deal internally with versioning and package management issues
    • +
  • Unfortunately, we must remove the quote from Paul because including it would require FDA approval.
    • +
  • Will also remove the FDA logo.
    • +
+

ACTION:

+
    +
  • Ning and the other authors will finalize the text.
    • +
  • JBR will send a MS word version of the post to Paul for final review.
    • +
+
+
+

Next meeting

+
    +
  • Because the July meeting is scheduled on the US July 4th holiday weekend and because of travel to the useR! conference the July meeting will be cancelled. * The next meeting of the submissions WG will be at 9AM Pacific Time on Friday August 2, 2022.
    • +
+ + +
+ + ]]> + https://rconsortium.github.io/submissions-wg/minutes/2024-06-07/ + Fri, 07 Jun 2024 00:00:00 GMT + Minutes 2024-05-03 Joseph Rickert @@ -2078,101 +2212,5 @@ View Attendee List https://rconsortium.github.io/submissions-wg/minutes/2022-11-04/ Fri, 04 Nov 2022 00:00:00 GMT - - Minutes 2022-10-07 - Joseph Rickert - https://rconsortium.github.io/submissions-wg/minutes/2022-10-07/ - - -
-
-
    -
  • Ellis Hughes (GSK)
    • -
  • Eric Nantz (Eli Lilly)
    • -
  • Honghong Zhou (Moderna)
    • -
  • Jizu Zhi (FDA)
    • -
  • Joseph Rickert (R Consortium)
    • -
  • Lei Zhao (Roche/Genentech)
    • -
  • Miriam Fossati (Merck)
    • -
  • Nan Xiao (Merck)
    • -
  • Ning Leng (Roche/Genentech)
    • -
  • Phil Bowsher (Posit)
    • -
  • Qin Li
    • -
  • Renping Zhang (Johnson & Johnson)
    • -
  • Robert Devine (Johnson & Johnson)
    • -
  • Ryan Johnson (Posit)
    • -
  • Saghir Bashir (Argenx)
    • -
  • Sam Parmar (Pfizer)
    • -
  • Sean Healey (Pfizer)
    • -
  • Tadeusz Lewandowski (Roche/Genentech)
    • -
  • Thomas Neitmann (Roche/Genentech)
    • -
  • Yilong Zhang (Meta)
    • -
-
-
- -

The meeting was recorded and the video is available.

-
-

Pilot 2 Submission

-

Ning began her update on the Pilot 2 Submission by thanking everyone who helped with the testing.

-

Status: The submission package is ready. However, the submissions team must address some last minute comments from the FDA. One comment is a request to mask p-values that are automatically reported. The apparent concern is that by default p-values will automatically be updated and reported when users filter the data by subgroups. Because we only have a small test data set this will likely lead to widely varying p-values which could be misinterpreted by general reviewers who are not statisticians. The FDA may request additional outputs to me masked. These comments appear to address the long term use of interactive applications in submissions and are not related to the technical aspects of making the submission.

-

Consequently, the meeting scheduled for next Tuesday which was intended for submitting Pilot 2 will now be devoted to addressing FDA comments. The team will reschedule the submission as soon as possible after addressing the comments. We do not anticipate a long delay. There are no technical difficulties with masking additional default outputs.

-

In the meantime more testing would be helpful and appreciated. Follow the instructions in the Appendix for Pilot 2: https://github.com/RConsortium/submissions-pilot2/issues/46 Put issues here: https://github.com/RConsortium/submissions-pilot2/issues/

-

JBR noted that there is now significant material in the GitHub repository for the working group which is indicative of the scope and scale of cooperation of the project. This is itself a success story of some interest.

-
-
-

Pilot 3 - ADaM

-

(13:51min into the video) Thomas Neitmann presented a proposal by Joel Laxamana and himself to extend Pilot 1 to include ADaM datasets programmed in R. The purpose of the proposal is to:

-
    -
  1. Demonstrate the viability of using R for ADaM dataset creation in the context of an FDA submission
    2. -
  2. Provide the industry with an end-to-end example of an R-based FDA filing
    3. -
-

Thomas’ presentation may be found here: https://github.com/RConsortium/submissions-wg/tree/main/Documents

-

Yilong suggested taking ODM XML as the source to make it more representative of an end-to-end process. This started a discussion about the value of beginning end-to-end examples from various different starting file formats.

-

The present team team includes:

-
    -
  • Thomas Neitmann - Roche (Co-Lead)
    • -
  • Joel Laxamana - Roche (Co-Lead)
    • -
  • Lei Zhao - Roche
    • -
  • Nicole Jones - Merck
    • -
-

The team is looking for additional help. Please have a look at the presentation and contact one of the Co-Leads if you would like to get involved.

-

The working group agreed to change the name of the project from Pilot 1-ADaM Extension to Pilot 3-ADaM to emphasize that the project will include a significant amount of new work.

-

Action Item JBR will make Paul Schuette aware of this new project and ask for his feedback.

-
-
-

DA Japan Talk

-

(31:30 min into video) Tadeusz presented a Shiny application that he developed for a presentation he is going to make at the DIA Japan conference on October 9, 2022. The intention of the presentation is to gauge the interest of the Japanese authorities. The session in which Tadeusz will present is called LS09 Innovative and Dynamic Statistical Analytics for Regulatory Submissions

-
-
-

Subgroups

-

The working group discussed writing writing some material for the GitHub repository explaining the purpose of the various subgroups, listing the members, and explaining how newcomers can get involved.

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Action Item Joe and Eric will meet after the Pilot 2 submission to discuss documenting the subgroups.

-
-
-

Containers

-

The working group agreed that the planned project to submit a containerized version of the Pilot 2 submission will require a significant amount of new work and pose several challenges. It should therefore be new, independent pilot submission, perhaps Pilot 4-Containers.

- - -
- - ]]> - https://rconsortium.github.io/submissions-wg/minutes/2022-10-07/ - Fri, 07 Oct 2022 00:00:00 GMT - diff --git a/minutes/2020-12-04/index.html b/minutes/2020-12-04/index.html index e49a168..17aa66a 100644 --- a/minutes/2020-12-04/index.html +++ b/minutes/2020-12-04/index.html @@ -2,7 +2,7 @@ - + diff --git a/minutes/2021-01-15/index.html b/minutes/2021-01-15/index.html index 087d7d8..7f3b7f7 100644 --- a/minutes/2021-01-15/index.html +++ b/minutes/2021-01-15/index.html @@ -2,7 +2,7 @@ - + diff --git a/minutes/2021-02-05/index.html b/minutes/2021-02-05/index.html index d951a79..9d64fdb 100644 --- a/minutes/2021-02-05/index.html +++ b/minutes/2021-02-05/index.html @@ -2,7 +2,7 @@ - + diff --git a/minutes/2021-03-05/index.html b/minutes/2021-03-05/index.html index 644b5e9..ba750ff 100644 --- a/minutes/2021-03-05/index.html +++ b/minutes/2021-03-05/index.html @@ -2,7 +2,7 @@ - + diff --git a/minutes/2021-04-05/index.html b/minutes/2021-04-05/index.html index f5fce6b..64765cb 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Minutes 2024-06-07

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Joseph Rickert

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Published
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June 7, 2024

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  • Ben Straub (GSK)
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  • Eva Li
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  • Heidi Curinckx (Johnson & Johnson)
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  • HyeSoo Cho (FDA)
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  • Ismael Alejandro Rodriguez (Appsilon)
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  • Jane Owens (Phuse & Eli Lilly)
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  • Joel Laxamana (Roche/Genentech)
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  • Joseph Rickert (R Consortium)
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  • Lovemore Gakava (Novo Nordisk)
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  • Ning Leng (Roche/Genentech)
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  • Paul Schuette (FDA)
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  • Saghir Bashir (Argenx)
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  • Stephanie Lussier (Moderna)
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  • Steven Hasendinckx (Johnson & Johnson)
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  • YounKyeong Chang (FDA)
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The meeting was recorded and the video is available.

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PharmaSUG Conference

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  • Both Ben Straub (Pilot 3) and Ismael Rodriguez (Pilot 4) gave talks at the recent Pharma SUG conference which was held in Baltimore.
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  • Both reported that there was a lot of interest in their talks
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  • Ben reported that he spoke to several people who thought the the FDA only approves SAS submissions.
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  • Both presentations will be placed in the R Submissions WG GitHub repository.
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Coordination with R Package Validation

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  • Ismael noted that Magnus from a package validation working group approached him about cooperating with the Submissions WG.
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  • JBR asked Ismael to ask Magnus to write to him and said that we be happy to invite Magnus to our meetings.
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Pilot 3

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Hye Soo Cho and YounKyeong Chang provided an update on their review of the Pilot 3 submission.

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  • The FDA eviewers are wrapping up their review.
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  • There are no major issues.
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  • They were able to install the Util package from the zip file and review the R programs to drive the ADaM data sets.
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  • QC of the ADRG did turn up a minor issue regarding inconsistencies among three date variables. +
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    • The discussion of this issue begins at 7:55 in the video and is illustrated in the screen capture below.
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    • The recommended solution is that the date origin should be specified in ISO 8601 date/time format in the ADRG.
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    • Joel agreed to review the record of issues with Pilot 3 and see if there are any other parameters that ought to be explicitly mentioned in the ADRG.
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Pilot 4

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Eric Nantz described progress on the Pilot 4 Submission.

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  • The end of June is still our target for the WebAssembly version of Pilot 4.
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  • The plan is to do the container version at a later time after the WebAssembly version has been reviewed.
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  • The question was asked if there are any special rules about package downloads.
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  • Paul Schuette stated that downloading from CRAN is preferable, that in addition to the serialization FDA Security has mentioned downloads as a potential security problem, but that as far as he knows there are no regulations.
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  • Eric pointed out that the Docker version of Pilot 4 also requires an image download.
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  • Eric and Paul will meet to discuss this issue.
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  • Eric will provide ADRG instructions and he and Paul will investigate,
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  • Paul noted that the FDA has recently approved WSL (Windows System Linux)
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ADRG

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There has been discussion within the working group as to whether we should investigate best practices for writing ADRGs for R based submissions. JBR noted that recent comments in issue #112 suggested that we should coordinated with the PHUSE ADRG working group. Discussion begins at 29:00 into the video.

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  • As it turned out Jane Owens (Eli Lilly) who is co-lead of the PHUSE ADRG working group was on the call.
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  • PHUSE owns the ADRG templates
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  • They are actively working on updating the templates with respect to R in section 7.1 of the template.
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  • Pilot 3 has documentation on R packages in Section 7 and in an appendix to the ADRG (Section 9).
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  • PHUSE got its starting point for updating the ADRG for R from J&J which Heidi Curinckx confirmed is based on J&J’s participation in the Submissions WG.
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  • The PHUSE WG will publish their updated template and then send it out for review
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  • The Submissions WG and the PHUSE ADRG WG will cooperate and share information.
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  • JBR invited Jane and other members of her WG to attend future meetings.
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R Versions Blog Post

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A small group led my Ning Leng is working on a blog post aimed at generating consensus about what versions of R might be appropriate for R based submissions at any point in time.

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  • The post has been revised to reelect the Submissions WG point of view and ends with a request for readers to comment in an issue that that we will open up on our GitHub repository.
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  • The post includes paragraphs on how four companies Roche, Lilly, GSK, Pfizer deal internally with versioning and package management issues
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  • Unfortunately, we must remove the quote from Paul because including it would require FDA approval.
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  • Will also remove the FDA logo.
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ACTION:

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  • Ning and the other authors will finalize the text.
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  • JBR will send a MS word version of the post to Paul for final review.
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Next meeting

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  • Because the July meeting is scheduled on the US July 4th holiday weekend and because of travel to the useR! conference the July meeting will be cancelled. * The next meeting of the submissions WG will be at 9AM Pacific Time on Friday August 2, 2022.
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"text": "Order By\n Default\n \n Date - Oldest\n \n \n Date - Newest\n \n \n Title\n \n \n Author\n \n \n \n \n \n \n \n\n\n\n\n\nDate\n\n\nTitle\n\n\nAuthor\n\n\n\n\n\n\nMay 3, 2024\n\n\nMinutes 2024-05-03\n\n\nJoseph Rickert\n\n\n\n\nApr 5, 2024\n\n\nMinutes 2024-04-05\n\n\nJoseph Rickert\n\n\n\n\nMar 1, 2024\n\n\nMinutes 2024-03-01\n\n\nJoseph Rickert\n\n\n\n\nFeb 2, 2024\n\n\nMinutes 2024-02-02\n\n\nJoseph Rickert\n\n\n\n\nJan 5, 2024\n\n\nMinutes 2024-01-05\n\n\nJoseph Rickert\n\n\n\n\nDec 1, 2023\n\n\nMinutes 2023-12-01\n\n\nJoseph Rickert\n\n\n\n\nNov 3, 2023\n\n\nMinutes 2023-11-03\n\n\nJoseph Rickert\n\n\n\n\nOct 6, 2023\n\n\nMinutes 2023-10-06\n\n\nJoseph Rickert\n\n\n\n\nSep 1, 2023\n\n\nMinutes 2023-09-01\n\n\nJoseph Rickert\n\n\n\n\nAug 4, 2023\n\n\nMinutes 2023-08-04\n\n\nJoseph Rickert\n\n\n\n\nJul 7, 2023\n\n\nMinutes 2023-07-07\n\n\nJoseph Rickert\n\n\n\n\nJun 2, 2023\n\n\nMinutes 2023-06-02\n\n\nJoseph Rickert\n\n\n\n\nMay 5, 2023\n\n\nMinutes 2023-05-05\n\n\nJoseph Rickert\n\n\n\n\nApr 7, 2023\n\n\nMinutes 2023-04-07\n\n\nJoseph Rickert\n\n\n\n\nMar 3, 2023\n\n\nMinutes 2023-03-03\n\n\nJoseph Rickert\n\n\n\n\nFeb 9, 2023\n\n\nMinutes 2023-02-03\n\n\nJoseph Rickert\n\n\n\n\nJan 13, 2023\n\n\nMinutes 2023-01-13\n\n\nEric Nantz\n\n\n\n\nDec 2, 2022\n\n\nMinutes 2022-12-02\n\n\nJoseph Rickert\n\n\n\n\nNov 4, 2022\n\n\nMinutes 2022-11-04\n\n\nJoseph Rickert\n\n\n\n\nOct 7, 2022\n\n\nMinutes 2022-10-07\n\n\nJoseph Rickert\n\n\n\n\nSep 2, 2022\n\n\nMinutes 2022-09-02\n\n\nJoseph Rickert\n\n\n\n\nAug 5, 2022\n\n\nMinutes 2022-08-05\n\n\nJoseph Rickert\n\n\n\n\nJul 1, 2022\n\n\nMinutes 2022-07-01\n\n\nJoseph Rickert\n\n\n\n\nJun 4, 2022\n\n\nMinutes 2022-06-04\n\n\nJoseph Rickert\n\n\n\n\nMay 6, 2022\n\n\nMinutes 2022-05-06\n\n\nJoseph Rickert\n\n\n\n\nMar 4, 2022\n\n\nMinutes 2022-03-04\n\n\nJoseph Rickert\n\n\n\n\nFeb 4, 2022\n\n\nMinutes 2022-02-04\n\n\nJoseph Rickert\n\n\n\n\nJan 7, 2022\n\n\nMinutes 2022-01-07\n\n\nJoseph Rickert\n\n\n\n\nDec 3, 2021\n\n\nMinutes 2021-12-03\n\n\nJoseph Rickert\n\n\n\n\nDec 3, 2021\n\n\nMinutes 2021-12-03\n\n\nJoseph Rickert\n\n\n\n\nNov 5, 2021\n\n\nMinutes 2021-11-05\n\n\nJoseph Rickert\n\n\n\n\nOct 1, 2021\n\n\nMinutes 2021-10-01\n\n\nJoseph Rickert\n\n\n\n\nSep 3, 2021\n\n\nMinutes 2021-09-03\n\n\nJoseph Rickert\n\n\n\n\nAug 6, 2021\n\n\nMinutes 2021-08-06\n\n\nJoseph Rickert\n\n\n\n\nJun 4, 2021\n\n\nMinutes 2021-06-04\n\n\nJoseph Rickert\n\n\n\n\nMay 7, 2021\n\n\nMinutes 2021-05-07\n\n\nJoseph Rickert\n\n\n\n\nApr 5, 2021\n\n\nMinutes 2021-04-05\n\n\nJoseph Rickert\n\n\n\n\nMar 5, 2021\n\n\nMinutes 2021-03-05\n\n\nJoseph Rickert\n\n\n\n\nFeb 5, 2021\n\n\nMinutes 2021-02-05\n\n\nJoseph Rickert\n\n\n\n\nJan 15, 2021\n\n\nMinutes 2021-01-15\n\n\nJoseph Rickert\n\n\n\n\nDec 4, 2020\n\n\nMinutes 2020-12-04\n\n\nJoseph Rickert\n\n\n\n\n\nNo matching items" + "text": "Order By\n Default\n \n Date - Oldest\n \n \n Date - Newest\n \n \n Title\n \n \n Author\n \n \n \n \n \n \n \n\n\n\n\n\nDate\n\n\nTitle\n\n\nAuthor\n\n\n\n\n\n\nJun 7, 2024\n\n\nMinutes 2024-06-07\n\n\nJoseph Rickert\n\n\n\n\nMay 3, 2024\n\n\nMinutes 2024-05-03\n\n\nJoseph Rickert\n\n\n\n\nApr 5, 2024\n\n\nMinutes 2024-04-05\n\n\nJoseph Rickert\n\n\n\n\nMar 1, 2024\n\n\nMinutes 2024-03-01\n\n\nJoseph Rickert\n\n\n\n\nFeb 2, 2024\n\n\nMinutes 2024-02-02\n\n\nJoseph Rickert\n\n\n\n\nJan 5, 2024\n\n\nMinutes 2024-01-05\n\n\nJoseph Rickert\n\n\n\n\nDec 1, 2023\n\n\nMinutes 2023-12-01\n\n\nJoseph Rickert\n\n\n\n\nNov 3, 2023\n\n\nMinutes 2023-11-03\n\n\nJoseph Rickert\n\n\n\n\nOct 6, 2023\n\n\nMinutes 2023-10-06\n\n\nJoseph Rickert\n\n\n\n\nSep 1, 2023\n\n\nMinutes 2023-09-01\n\n\nJoseph Rickert\n\n\n\n\nAug 4, 2023\n\n\nMinutes 2023-08-04\n\n\nJoseph Rickert\n\n\n\n\nJul 7, 2023\n\n\nMinutes 2023-07-07\n\n\nJoseph Rickert\n\n\n\n\nJun 2, 2023\n\n\nMinutes 2023-06-02\n\n\nJoseph Rickert\n\n\n\n\nMay 5, 2023\n\n\nMinutes 2023-05-05\n\n\nJoseph Rickert\n\n\n\n\nApr 7, 2023\n\n\nMinutes 2023-04-07\n\n\nJoseph Rickert\n\n\n\n\nMar 3, 2023\n\n\nMinutes 2023-03-03\n\n\nJoseph Rickert\n\n\n\n\nFeb 9, 2023\n\n\nMinutes 2023-02-03\n\n\nJoseph Rickert\n\n\n\n\nJan 13, 2023\n\n\nMinutes 2023-01-13\n\n\nEric Nantz\n\n\n\n\nDec 2, 2022\n\n\nMinutes 2022-12-02\n\n\nJoseph Rickert\n\n\n\n\nNov 4, 2022\n\n\nMinutes 2022-11-04\n\n\nJoseph Rickert\n\n\n\n\nOct 7, 2022\n\n\nMinutes 2022-10-07\n\n\nJoseph Rickert\n\n\n\n\nSep 2, 2022\n\n\nMinutes 2022-09-02\n\n\nJoseph Rickert\n\n\n\n\nAug 5, 2022\n\n\nMinutes 2022-08-05\n\n\nJoseph Rickert\n\n\n\n\nJul 1, 2022\n\n\nMinutes 2022-07-01\n\n\nJoseph Rickert\n\n\n\n\nJun 4, 2022\n\n\nMinutes 2022-06-04\n\n\nJoseph Rickert\n\n\n\n\nMay 6, 2022\n\n\nMinutes 2022-05-06\n\n\nJoseph Rickert\n\n\n\n\nMar 4, 2022\n\n\nMinutes 2022-03-04\n\n\nJoseph Rickert\n\n\n\n\nFeb 4, 2022\n\n\nMinutes 2022-02-04\n\n\nJoseph Rickert\n\n\n\n\nJan 7, 2022\n\n\nMinutes 2022-01-07\n\n\nJoseph Rickert\n\n\n\n\nDec 3, 2021\n\n\nMinutes 2021-12-03\n\n\nJoseph Rickert\n\n\n\n\nDec 3, 2021\n\n\nMinutes 2021-12-03\n\n\nJoseph Rickert\n\n\n\n\nNov 5, 2021\n\n\nMinutes 2021-11-05\n\n\nJoseph Rickert\n\n\n\n\nOct 1, 2021\n\n\nMinutes 2021-10-01\n\n\nJoseph Rickert\n\n\n\n\nSep 3, 2021\n\n\nMinutes 2021-09-03\n\n\nJoseph Rickert\n\n\n\n\nAug 6, 2021\n\n\nMinutes 2021-08-06\n\n\nJoseph Rickert\n\n\n\n\nJun 4, 2021\n\n\nMinutes 2021-06-04\n\n\nJoseph Rickert\n\n\n\n\nMay 7, 2021\n\n\nMinutes 2021-05-07\n\n\nJoseph Rickert\n\n\n\n\nApr 5, 2021\n\n\nMinutes 2021-04-05\n\n\nJoseph Rickert\n\n\n\n\nMar 5, 2021\n\n\nMinutes 2021-03-05\n\n\nJoseph Rickert\n\n\n\n\nFeb 5, 2021\n\n\nMinutes 2021-02-05\n\n\nJoseph Rickert\n\n\n\n\nJan 15, 2021\n\n\nMinutes 2021-01-15\n\n\nJoseph Rickert\n\n\n\n\nDec 4, 2020\n\n\nMinutes 2020-12-04\n\n\nJoseph Rickert\n\n\n\n\n\nNo matching items" }, { "objectID": "minutes/2022-12-02/index.html", @@ -63,298 +63,319 @@ "text": "View Attendee List\n\n\n\n\n\n\n“Beverly Chin - Roche”\n“Heidi Curinckx - Johnson & Johnson”\n“Bob Engle - BioGen”\n“Miriam Fossati - Merck”\n“Steven Hassendinckx”\n“Christopher Kania - Biogen”\n“Ning Leng - Genentech”\n“Eric Nantz - Eli Lilly”\n“Tim Powell - Biogen”\n“Joseph Rickert - R Consortium”\n“Paul Schuette - FDA”\n“Ben Staub - GSK”\n“Adrian Waddell - Roche”\n“Heng Wang - Genentech”\n“Peikun Wu - Merck”\n“Nan Xiao - Merck”\n“Hong Yaan - Regeneron”\n“Renping Zhang - FDA”\n“Yilong Zhang - Merck”\n“Jizu Zhi - FDA”\n\n\n\n\nJoseph Rickert brought the meeting to order and stated that with Eli’s help he was able to reactivate the FDA gateway and asked those with the passport to login and make sure there are no other impediments. The details are:\nThe R Consortium account has been reactivated: To access the R Consortium account, please, use this URL: https://esgtest.fda User ID: joseph.rickert@rstudio.com Password: Please see Ning, Yilong, Eli or Joe The Portal is : https://esgtest.fda.gov/\nHe then asked Ning to introduce Beverly Chin from Roche and Tim Powell from Biogen who are both experienced in making regulatory submissions.\nNing provided a brief overview of the project and an update on progress since the last meeting which included recruiting new members for the working group from presenting at the R/Pharma conference and a new project website (https://rconsortium.github.io/submissions-wg/) built by Eric Nantz.\nAsks to members We need more people to review the submission package. Bob Engle volunteered Nate Mockler (nate.mockler@biogen.com) as a reviewer. Identify FDA members who can do the review. (Paul said that he has two candidates.)\nBeverly asked some clarifying questions and we confirmed that We are using the test gateway CDER will be the center It is a formal package\nNing then went over some feedback provided by reviewers so far. The most important issue was Inconsistent table layouts. However, Ning pointed out that using multiple table layouts is intentional. The objective is to have three tables follow different company specific standards in order to cover tables built with different R packages. Ning said that we will add a disclaimer to the report in order to inform the FDA reviewers of our objectives.\nReviewers also flagged some things that are not consistent with best practices, such as including the number of individuals at risk on Kaplan-Meier curves.\nJoe asked Ning to review the contents of the Pilot 1 repo\nNing explained the reviewer comments on issue #47 on the Kanban Board. Ning will link the GitHub issue to a google drive containing more material.\nThe group then discussed a timeline for the remainder of the project and settled on the key dates: Package to be complete and ready to go by end of Friday, 2021-11-19 Submission to be made on Monday 2021-11-22 Joe took the action item to setup a zoom meeting for 9AM PT time on 11-22\nThere followed an extended discussion about whether to use .txt or .r for the R files. The FDA documentation says they will accept both, however, some people Including FDA folks might reject a .r file because they misunderstand the documentation. On the other hand, getting a .r through would be a big win on its own.\nIt was also suggested to include a separate README document to describe how the package is constructed.\nAt 36.33 into the video Paule Schuette of the FDA shares a slide his colleague Heather Crandall presented recently at the R/Pharma conference about eCTD placement of Study Data Files.\n\n\n\nCTD triangle\n\n\nNote that R Markdown and R are listed among accepted eCTD format types.\nAt 44.33, “Scrum master” Adrian Waddell leads the group through adding new tasks to the Kanban board: https://github.com/RConsortium/submissions-wg/projects/2\nSummary of tasks leading to Submission\nFirst round of adjudication by 2021-11-11 Decide about submitting .r files 2021-11-11 Adjudication by 2021-11-18 Final Review 2021-11-19 by Eric Nantz, Adrian and Nate Mockler Ning and Yilong will address the comments. Submission on 2021-11-22 Ning Leng, Yilong Zhang, Paul Schuette, Beverely Chin, Tim Powell and Joe Rickert will participate in the Submission meeting. The meeting will be recorded.\nJoe took the action item to setup a zoom meeting for 9AM PT time on 2021-11-22 to make the submission.\nThe video of today’s 11-5-21 meeting is available here passcode: L*jwHXn5\nThe next meeting is scheduled for Friday, 2021-12-03." }, { - "objectID": "minutes/2023-11-03/index.html", - "href": "minutes/2023-11-03/index.html", - "title": "Minutes 2023-11-03", + "objectID": "minutes/2024-06-07/index.html", + "href": "minutes/2024-06-07/index.html", + "title": "Minutes 2024-06-07", "section": "", - "text": "Minutes prepared by Joseph Rickert and Joel Laxamana.\n\n\n\n\n\n\nView Attendee List\n\n\n\n\n\n\nBen Straub (GSK)\nDadong Zhang (Illumina)\nEric Nantz (Eli Lilly)\nHyeSoo Cho (FDA)\nJizu Zhi (FDA)\nJoel Laxamana (Roche/Genentech)\nKaushal Shah\nNan Xiao (Merck)\nPaul Schuette (FDA)\nRobert Devine (Johnson & Johnson)\nSaghir Bashir (Argenx)\nSam Parmar (Pfizer)\nJoseph Rickert (ProCogia)\nIsmael Alejandro Rodriguez Rodriguez (Appsilon)\nYilong Zhang (Meta)\nYounKyeong Chang\n\n\n\n\nThe meeting was recorded and the video is available.\n\nFDASA Presentation\n\nThe FDASA would like to invite the R Consortium to present at their meeting on December 11, 2023 (3 to 4:30PM ET).\nHowever the FDASA would like to extend an informal invitation rather than formally sponsor the event which would require administrative approvals\nThe RC would still be able to advertise that Paul and HyeSoo are speaking\nThe RC would conduct the event which is expected to attract at least 200 of the approximately 400 FDASA participants.\nRegistration of the event is not required\nThe RC can also invite the general public to attend. (JBR will confer with Ning and Eric about doing this.)\nJBR will s=send an invitation to the event, which should include the abstract, to Paul to be used to invite FDASA members to the event through internal channels.\n\n\n\nPilot 3\nHeySoo and Paul provide some preliminary comments regarding their evaluation of Pilot 3. An extensive discussion starts approximately 12 minutes into the video recording.\n\nThe ADRG states that Pilot 3 was uses R 4.2.3. However, FDA may test using different R versions. (i.e. one reviewer using Rv4.2.1 and other using Rv4.2.3). There are at least two kinds of workstations used by FDA reviewers. Reviewers with “scientific workstations” may have administrative privileges and be able to install R. Users on other “regulatory” workstations will most likely use the version of R installed by IT.\nThe Pilot 3 package didn’t install using renv::install() when using Rv4.2.1, but did install when the reviewer was using Rv4.2.3.\nThe submissions programs which process ADaM data were not updated to match the file adam-pilot-3.xlsx which was included in the submission.\nReviewers were able to update the file name. When they did so the adsl.r ran fine.\nDo not include notes to change the path to source data file in the ADRG steps. Instead, keep a note open to advise reviewers that they “should change the source data path to the location where the data was downloaded from the EDR”.\nThe submission documentation should include the version of the Microsoft operating system used along with the the version of the RStudio IDE used.\nSponsors using proprietary software also encounter Operating system issues. There may also be issues with respect to a difference in the size and power of the computers used by the sponsors and those available to the FDA reviewers.\nThere may be problems if file names using upper case letters are used in submissions. The FDA technical conformance guide specifies the use of lower case letters.\n\nThe next meeting of the Submissions WG will be held at 9AM Pacific Time on Friday, December 8, 2023." + "text": "View Attendee List\n\n\n\n\n\n\nBen Straub (GSK)\nEva Li\nHeidi Curinckx (Johnson & Johnson)\nHyeSoo Cho (FDA)\nIsmael Alejandro Rodriguez (Appsilon)\nJane Owens (Phuse & Eli Lilly)\nJoel Laxamana (Roche/Genentech)\nJoseph Rickert (R Consortium)\nLovemore Gakava (Novo Nordisk)\nNing Leng (Roche/Genentech)\nPaul Schuette (FDA)\nSaghir Bashir (Argenx)\nStephanie Lussier (Moderna)\nSteven Hasendinckx (Johnson & Johnson)\nYounKyeong Chang (FDA)\nThe meeting was recorded and the video is available." }, { - "objectID": "minutes/2023-05-05/index.html", - "href": "minutes/2023-05-05/index.html", - "title": "Minutes 2023-05-05", - "section": "", - "text": "View Attendee List\n\n\n\n\n\n\nAndrew Borgman (Bristol Myers Squibb)\nBen Straub (GSK)\nBrandon Suchon\nEric Nantz (Eli Lilly)\nHyeSoo Cho (FDA)\nJizu Zhi (FDA)\nJoel Laxamana (Roche/Genentech)\nJoseph Rickert (R Consortium)\nKui Shen (Bayer)\nNan Xiao (Merck)\nNate Mockler (Biogen)\nPaul Schuette (FDA)\nRenping Zhang (Johnson & Johnson)\nRobert Devine (Johnson & Johnson)\nSaghir Bashir (Argenx)\nSam Parmar (Pfizer)\nSean Healey (Pfizer)" + "objectID": "minutes/2024-06-07/index.html#pharmasug-conference", + "href": "minutes/2024-06-07/index.html#pharmasug-conference", + "title": "Minutes 2024-06-07", + "section": "PharmaSUG Conference", + "text": "PharmaSUG Conference\n\nBoth Ben Straub (Pilot 3) and Ismael Rodriguez (Pilot 4) gave talks at the recent Pharma SUG conference which was held in Baltimore.\nBoth reported that there was a lot of interest in their talks\nBen reported that he spoke to several people who thought the the FDA only approves SAS submissions.\nBoth presentations will be placed in the R Submissions WG GitHub repository." }, { - "objectID": "minutes/2023-05-05/index.html#add-minutes-here", - "href": "minutes/2023-05-05/index.html#add-minutes-here", - "title": "Minutes 2023-05-05", - "section": "Add Minutes Here", - "text": "Add Minutes Here\nThe meeting was recorded and the video is available.\nJoseph Rickert brought the meeting to order.\n\nPilot 2\n\nHye Soo Cho of the FDA reported that her review of the Pilot 2 submission is going well and that she expects to be finished in June.\nShe is not sure how long it will take the FDA to produce a written response.\n\n\n\nPilot 3\nJoel Laxamana reported on Pilot 3 work.\n\nThe execution team isfocusing on documentation particularly in the ADRG.\nThe WG confirmed that Pilot 3 should follow the Pilot 2 approach and send the renv.lock file in the R package text.\nThere was a question about SDTM Versions. The WG confirmed that the Pilot 3 should use the same 1.4 STDM version as Pilots 1 and 2. See Issue #104.\nQC Findings will go as Appendix to the ADRG.\nThe WG agreed that the second week in July would be a good target for Pilot 3 Submission.\n\n\n\nPilot 4\nEric Nantz provided an update on Pilot 4 work.\n\nEric expects to have the first meeting of the execution team volunteers in the next few weeks.\nEric is taking a step back from committing to a container based approach in order to consider the possibility of using a self executing app in the browser using WebAssembly.\nGeorge Stagg from Posit is providing some assistance.\nThe idea is that the R submission code would run in a browser on the local machine of an FDA analyst.\nPaul Schuette indicated that this approach would likely be possible at the FDA.\nEric said that he would be happy to try and replicate the FDA web browser environment.\nThe group suggested that a Webinar for the R Adoption series and other venues would be valuable for promoting the project.\nPaul speculated that this web browser technology might also be useful to FDA field inspectors.\nEric noted that a selection core of R packages is being identified to have them run run “out of the box”.\nIf you would like to be part of the Pilot 4 team please contact Eric Nantz.\nPaul noted that recent events where outside entities can re-litigate FDA approvals decades after the approval could make it even more necessary to be able to run analysis software many years after the submission.\nJBR surmised that there may be interest in WG to explore long term archiving.\n\n\n\nOther discussions\n\nNan Xiao brought attention to a document describing the submission WG in Japan. It refers to a survey about open source that mentions the Pilot 1 Submissions.\nWe are exploring the possibility of arranging for the authors of this document to participation in an R Adoption Series webinar.\n\nThe next meeting of the Submissions WG will be on Friday, June 2, 2023 at 9AM Pacific Time." + "objectID": "minutes/2024-06-07/index.html#coordination-with-r-package-validation", + "href": "minutes/2024-06-07/index.html#coordination-with-r-package-validation", + "title": "Minutes 2024-06-07", + "section": "Coordination with R Package Validation", + "text": "Coordination with R Package Validation\n\nIsmael noted that Magnus from a package validation working group approached him about cooperating with the Submissions WG.\nJBR asked Ismael to ask Magnus to write to him and said that we be happy to invite Magnus to our meetings." }, { - "objectID": "minutes/2021-06-04/index.html", - "href": "minutes/2021-06-04/index.html", - "title": "Minutes 2021-06-04", - "section": "", - "text": "View Attendee List\n\n\n\n\n\n\n“Sascha Ahrweiler - Bayer”\n“Ethan Chen - FDA”\n“Heather Crandall - FDA”\n“Bob Engle - Biogen”\n“Bella Feng -”\n“Steven Hasendinckx - J&J”\n“Chris Kania - Biogen”\n“Doug Kelkhoff - Genentech”\n“Ning Leng - Genentech”\n“Tadeusz Lewandowski - Roche”\n“Eli Miller - Atorus”\n“Eric Nantz - Lilly”\n“Joseph Rickert - R Consortium”\n“Paul Schuette - FDA”\n“Ojesh Upadhyay - GSK”\n“Adrian Waddell - Roche”\n“Nan Xiao - Merck”\n“Jiang Xu - FDA”\n“Yilong Zhang - Merck”\n\n\n\n\nNote that the bold numbers in the minutes are time stamp references for the video recording.\nJoseph Rickert opened the meeting by welcoming guests from the FDA Ethan Chen, Heather Crandall and Jiang Xu and giving brief description of the R Consortium and its mission.\nJoe then summarized the purpose of the meeting: the Submissions working group is working on a pilot submission to the FDA that would test whether an “all R” submission could pass the submssions process and be easily consumable by the FDA reviewers. Furthermore, the group would like to have the R Consortium act as the sponsor of the pilot submission, and is looking for guidance to determine if this is possible.\n6:31 Ethan Chen expressed a desire to support the R Consortium initiative and mentioned that R is currently included as a supported file eCTD file format. See Specifications for File format Types Using eCTD Specifications.\n15:00 1. Test the exchange mechanism through the gateway and routing to the specific in the review division 2. Once received, can they be open and reviewed\nEthan stated that his team is involved mainly with the exchange method.\n15:30 In general, to initiate an a submission in a production environment an organization must open an ESG Accoount. This process includes requesting an account and writing a Non-Repudiation letter to the FDA. (See the AS2 Account Checklist). The FDA then will assign an application number.\n19:32 Doug Kelkhoff asks if it is possible for a non-profit such as the R Consortium could be a sponsor. Jiang Xu believes it is possible but will require further discussion.\n22:40 Adrian Waddell describes the interplay of the exchange and review processes.\n23:00 Ethan Chen outlines two major concerns:\n\nSecurity (Executable files not accepted)\nTo meet the error records management requirement the FDA must be able to open any submitted file for the entire retention period which could be up to 30 years.\n\n26:00 Joe ask Ethan if there is someone in particular who could help setting up the ESG account. Ethan replies that Heather and Jiang could help and also help to determine if the R Consortium could be a sponsor.\n26:55 Heather Crandall recommends becoming familiar with the requirements on the ESG Webpage.\n28:00 Doug Kelkhoff initiates a discussion of the challenges that the working group is hoping to address.\nThe ask right now is for the working group to understand what steps we must undertake and who would be our FDA contact is we get stuck.\n30:15 Jiang Xu states that the FDA would want to know exactly what things we think the FDA would need to test and notes that different FDA offices and centers would need to be involved.\n34:00 Yilong Zhang points out that a goal of the working group is to test how internally R packages could be transmitted to the FDA as part of a submission.\n35:25 Doug Kelkhoff describes challenges including file extensions and case sensitivity\n36:55 Adrian Weddell notes that if the working group is able to successfully make a pilot submission and put it out in the open it would provide a guide for other companies to follow. He also raised the issue of probing the security issues around the way R packages often require dependent packages to be installed.\n40:10 Bell Feng compares an R script to a SAS macro and asks for clarification about how we are using packages. Doug Kelkhoff clarifies that the issue is about the using R best practices and being able to install packages required to perform and analysis and not just submit R scripts.\n50:00 Joe asks if there are any other FDA offices or groups that the working group should contact. Jiang and Heather do not think any other contacts are necessary to contact at this time. Jiang indicates that they will discuss this within the FDA.\nThe group agreed to meet next on Wednesday June 30, 2021.\nThe video of the meeting is available here Passcode: V@.?eq85\nAction Items for the Working Group\n\nGenerate a list of potential issues and items that we think the FDA will want to evaluate.\nBecome familiar with process and requirements for opening an ESG account as described on the Electronic Submissions Gateway site." + "objectID": "minutes/2024-06-07/index.html#pilot-3", + "href": "minutes/2024-06-07/index.html#pilot-3", + "title": "Minutes 2024-06-07", + "section": "Pilot 3", + "text": "Pilot 3\nHye Soo Cho and YounKyeong Chang provided an update on their review of the Pilot 3 submission.\n\nThe FDA eviewers are wrapping up their review.\nThere are no major issues.\nThey were able to install the Util package from the zip file and review the R programs to drive the ADaM data sets.\nQC of the ADRG did turn up a minor issue regarding inconsistencies among three date variables.\n\nThe discussion of this issue begins at 7:55 in the video and is illustrated in the screen capture below.\nThe recommended solution is that the date origin should be specified in ISO 8601 date/time format in the ADRG.\nJoel agreed to review the record of issues with Pilot 3 and see if there are any other parameters that ought to be explicitly mentioned in the ADRG." }, { - "objectID": "minutes/2021-02-05/index.html", - "href": "minutes/2021-02-05/index.html", - "title": "Minutes 2021-02-05", - "section": "", - "text": "View Attendee List\n\n\n\n\n\n\n“Joseph Rickert - R Consortium”\n“Adrian Waddell - Roche”\n“Paul Schuette - FDA”\n“Bella Feng - EQRx”\n“Yilong Zhang - Merck”\n“Eric Nantz - Lilly”\n“Doug Kelkhoff - Genentech”\n“Mike Stackhouse - Atorus Research”\n“Nan Xiao - Merck”\n“Ning Leng - Genentech”\n“Sascha Ahrweiler - Bayer”\n“Steven Hasendinckx J&J”\n“Phil Bowsher - RStudio”\n“Bob Engle - Biogen”\n\n\n\n\nJoseph Rickert brought the meeting to order, reminded everyone of the GitHub repo for the working group where minutes and other documents are kept, and summarized the goal articulated in the previous meeting to develop a pilot environment to study approaches for creating R submissions.\nMike Stackhouse noted that the group should focus on creating an environment that was “consumable” by the FDA. Paul Schuette agreed with this. He noted that the experiment he did with Eric Nantz two years ago (discussed in a previous meeting) was the closest he has come so far.\nNext followed a discussion about the FDA computing environment, a discussion thread that developed over the course of the meeting. Some key points are:\n\nFDA reviewers and researchers work primarily on desktop machines that mostly run Windows 10.\nThere are two classes of desktop computers 1) regulatory computers and 2) scientific computers.\nThe scientific computers are not as rigorously controlled as the scientific computers.\nPaul has installed Ubuntu on a few of the scientific computers\nDesktop computers run SAS version 9.4, but the build may differ\nA perceived advantage of SAS is that it generally runs older software\nThere is a pilot project going on at the FDA to run SAS on a server, which would ensure a common build.\nWhen asked: If the FDA decided to move to Linux, how long would it take to convert all of the desktops from Windows to Linux, Paul speculated that it would take a minimum of two years. The implication is that Windows is not going away anytime soon.\nWhen asked about the installation of R packages, Paul indicated that installation was not a problem.\nObtaining R packages is more of an issue. In theory, the FDA could use MRAN or some other repository which enables downloading specific versions of packages.\n\nThe discussion turned to considering section 4.1.2.10 of the Study Data Technical Performance Guide:\n\nYilong Zhang stated that his company has focused on the sentence: “The Specific Software utilized should be specified in the ADRG.” Mike Stackhouse explained that the PHUSE working group is is leading is also focused on interpreting this sentence.\nPaul noted that companies are obligated to use the SAS export file format, but are not obligated to use SAS. Bella Feng noted that a recent FDA oncology pilot explicitly specifies SAS.\nPaul noted that many FDA analyses are hybrid using both SAS and R. The group acknowledge that all R submissions were the ultimate goal, we should be planning to work with mixed submissions for some time.\nMike Stackhouse stated that, although there are many corner cases, we should focus on building a reference platform along the lines of least resistance and go for what is easily achievable. The group generally agreed with this.\nTowards the end of the meeting Paul mentioned that although the that section 4.1.2.10 specifies that programs should be submitted as text files, it does not mean that .txt extensions must be used. This surprised everyone. When asked if the FDA document could be revised to make this more clear, Paul stated that it was possible. He said that the document is generally revised once or twice a year, the most recent revision is dated Nov 20, 2020.\nAction Item: Paul stated that if the group wanted to suggest the wording to revise the document, he would submit it to the responsible FDA committee. He noted that to make the change it would need to be approved by the committee and go through the normal approval process.\nJoseph Rickert asked the group to use the repo to submit their suggested changes to the wording about using text, and reminded everyone that the next meeting was set for Friday, March 5, 2021.\nJoseph Rickert, Mike Stackhouse and Sascha Ahrweiler agreed to meet before the next Submissions group meeting to try and map out the various PHUSE, PSI and R Consortium working groups that are doing similar or complementary work.\nThe link to the video of the meeting is: https://zoom.us/rec/share/gFQancacysPFHm0Czrw3sAYOCrt35BgTbcodBdY2LGld4fkykDypkL99PX5o0i-c.JRCWwmZfO9Ui8G6f\nPasscode: +GKR9&i6" + "objectID": "minutes/2024-06-07/index.html#pilot-4", + "href": "minutes/2024-06-07/index.html#pilot-4", + "title": "Minutes 2024-06-07", + "section": "Pilot 4", + "text": "Pilot 4\nEric Nantz described progress on the Pilot 4 Submission.\n\nThe end of June is still our target for the WebAssembly version of Pilot 4.\nThe plan is to do the container version at a later time after the WebAssembly version has been reviewed.\nThe question was asked if there are any special rules about package downloads.\nPaul Schuette stated that downloading from CRAN is preferable, that in addition to the serialization FDA Security has mentioned downloads as a potential security problem, but that as far as he knows there are no regulations.\nEric pointed out that the Docker version of Pilot 4 also requires an image download.\nEric and Paul will meet to discuss this issue.\nEric will provide ADRG instructions and he and Paul will investigate,\nPaul noted that the FDA has recently approved WSL (Windows System Linux)" }, { - "objectID": "minutes/2024-03-01/index.html", - "href": "minutes/2024-03-01/index.html", - "title": "Minutes 2024-03-01", - "section": "", - "text": "View Attendee List\n\n\n\n\n\n\nEric Nantz (Eli Lilly)\nHeidi Curinckx (Johnson & Johnson)\nHyeSoo Cho (FDA)\nJizu Zhi (FDA)\nJoel Laxamana (Roche/Genentech)\nJoseph Rickert (JBR) (R Consortium)\nLovemore Gakava (Novo Nordisk)\nNan Xiao (Merck)\nNicholas Masel (JRDUS)\nNing Leng (Roche/Genentech)\nPaul Schuette (FDA)\nRobert Devine (Johnson & Johnson)\nSaghir Bashir (Argenx)\nSam Parmar (Pfizer)\nYoun Kyeong Chang (FDA)\n\nThe meeting was recorded and the video is available." + "objectID": "minutes/2024-06-07/index.html#adrg", + "href": "minutes/2024-06-07/index.html#adrg", + "title": "Minutes 2024-06-07", + "section": "ADRG", + "text": "ADRG\nThere has been discussion within the working group as to whether we should investigate best practices for writing ADRGs for R based submissions. JBR noted that recent comments in issue #112 suggested that we should coordinated with the PHUSE ADRG working group. Discussion begins at 29:00 into the video.\n\nAs it turned out Jane Owens (Eli Lilly) who is co-lead of the PHUSE ADRG working group was on the call.\nPHUSE owns the ADRG templates\nThey are actively working on updating the templates with respect to R in section 7.1 of the template.\nPilot 3 has documentation on R packages in Section 7 and in an appendix to the ADRG (Section 9).\n\n\n\nPHUSE got its starting point for updating the ADRG for R from J&J which Heidi Curinckx confirmed is based on J&J’s participation in the Submissions WG.\nThe PHUSE WG will publish their updated template and then send it out for review\nThe Submissions WG and the PHUSE ADRG WG will cooperate and share information.\nJBR invited Jane and other members of her WG to attend future meetings." }, { - "objectID": "minutes/2024-03-01/index.html#plot-3-update", - "href": "minutes/2024-03-01/index.html#plot-3-update", - "title": "Minutes 2024-03-01", - "section": "Plot 3 Update", - "text": "Plot 3 Update\n\nFDA Recommendation\nHyeSoo stated that the FDA is considering issuing a recommendation that submissions sponsors should use the most recent patch version of the previous minor version of R.\nFor example, R versions are organized as V x.y.z where:\n\nx is the major version\ny is the minor version or subversion\nz is the patch version\n\nThe WG members affirmed that a policy of using a proven stable version of R and not the latest version is in accordance with the practices of their respective companies.\nAfter some thought the working group proposed that since patch versions are issued frequently (every couple of months), it might be better to have the FDA guidance suggest the last patch version of the previous subversion.\nNote that the FDA is considering making a recommendation and not considering setting policy.\nAction: JBR will confer with Sam, Paul and HyeSoo about the wording of the recommendation and then draft a blog post. The post will go to Paul, HyeSoo, Eric, and Ning for review before being published on the R Consortium Blog." + "objectID": "minutes/2024-06-07/index.html#r-versions-blog-post", + "href": "minutes/2024-06-07/index.html#r-versions-blog-post", + "title": "Minutes 2024-06-07", + "section": "R Versions Blog Post", + "text": "R Versions Blog Post\nA small group led my Ning Leng is working on a blog post aimed at generating consensus about what versions of R might be appropriate for R based submissions at any point in time.\n\nThe post has been revised to reelect the Submissions WG point of view and ends with a request for readers to comment in an issue that that we will open up on our GitHub repository.\nThe post includes paragraphs on how four companies Roche, Lilly, GSK, Pfizer deal internally with versioning and package management issues\nUnfortunately, we must remove the quote from Paul because including it would require FDA approval.\nWill also remove the FDA logo.\n\nACTION:\n\nNing and the other authors will finalize the text.\nJBR will send a MS word version of the post to Paul for final review." }, { - "objectID": "minutes/2024-03-01/index.html#pilot-3-update", - "href": "minutes/2024-03-01/index.html#pilot-3-update", - "title": "Minutes 2024-03-01", - "section": "Pilot 3 Update", - "text": "Pilot 3 Update\nHyeSoo and Joel informed the group that they met last month to resolve the discrepancy between the original CDISC version of the ADADAS ADaM data set and the Pilot 3 version of the ADaM data set. Joel noted that there are 818 available records in the QS domain. The CDISC ADADAS only brought in 799 records and imputed the rest, whereas Pilot 3 brought in all available 818 records into ADADAS and then imputed. When the Pilot 3 team adjusted by subsetting to ANL01FL=‘Y’ records first before doing the LOCF imputation the results matched Pilot 1 and the discrepancy was resolved. Look here for details.\nThis issue illustrates the level of detail that the FDA must consider in replicating a sponsor’s submission environment. This particular issue was due to a statistical decision and not an error. Ning pointed out that most of the work in resolving discrepancies over the three Pilot submissions are due to insufficient documentation and inadequate communication and not to differences between SAS and R.\nAction: Ning and Joe will work on a blog post about this topic." + "objectID": "minutes/2024-06-07/index.html#next-meeting", + "href": "minutes/2024-06-07/index.html#next-meeting", + "title": "Minutes 2024-06-07", + "section": "Next meeting", + "text": "Next meeting\n\nBecause the July meeting is scheduled on the US July 4th holiday weekend and because of travel to the useR! conference the July meeting will be cancelled. * The next meeting of the submissions WG will be at 9AM Pacific Time on Friday August 2, 2022." }, { - "objectID": "minutes/2024-03-01/index.html#rmedicine", - "href": "minutes/2024-03-01/index.html#rmedicine", - "title": "Minutes 2024-03-01", - "section": "R/Medicine", - "text": "R/Medicine\nJoel has been invited to give a talk at the upcoming R/Medicine virtual conference which will be held from June 10 to 14. He is deciding whether to give a talk or a workshop." + "objectID": "minutes/2022-06-04/index.html", + "href": "minutes/2022-06-04/index.html", + "title": "Minutes 2022-06-04", + "section": "", + "text": "View Attendee List\n\n\n\n\n\n\nBob Engle (Biogen)\nEllis Hughes (GSK)\nGabriel Becker (Roche/Genentech)\nGregory Chen (MSD)\nJizu Zhi (FDA)\nJoseph Rickert (R Consortium)\nKui Schen (Bayer)\nMichael Blanks (BeiGene)\nNan Xiao (Merck)\nPhanikumar Tata (Syneos Health)\nPhil Bowsher (Posit)\nRobert Devine (Johnson & Johnson)\nRyan Johnson (Posit)\nSean Healey (Pfizer)\nSteven Hasendinckx (Johnson & Johnson)\nTadeusz Lewandowski (Roche/Genentech)\nXin Qiu (Johnson & Johnson)\n\n\n\n\nUnfortunately, the video of the meeting is not available.\nJBR began the meeting with this agenda:\n\nPilot 2 Status Update\nR Adoption Webinar\nPilot 3 Status?\nJapan Submission Status?\nChina Submission Status?\nReview project Board\nOpen Discussion\n\n\nPilot 2 Status\nThe following status was provided in an email to JBR by Ning Leng\n\nThe Pilot 2 team is addressing feedback from this working group\nThe Roche “NEST” software, which includes the teal package, is scheduled to be open sourced in mid June.\nAfter teal open source: Pilot 2 team will package up the shiny app code using the golem package.\nPilot 2 is on track for July Submission\n\nJBR asked the following questions:\n\nWill teal be put on CRAN?\nIs the gateway ready?\nIs the cover letter for Pilot 2 fine?\n\nNo one present was sure whether the teal package would be submitted to CRAN before the submission or whether the Pilot 2 submission would be made with this package on GitHub. Tad L. noted teal will have an Apache 2.0 license.\nTad Lewandowski noted that the Pilot 2 execution team received several helpful comments on the shiny app. The team plans to keep the initial app as simple as possible and will consider the ideas proposed in the comments as extensions for the future. He also noted hat the Roche team has built additional shiny apps that have been made public and are available for use in future submissions that collectively form a “clinical studies results viewer”. These include:\n\nEfficacy\nExploratory\nSafety\n\nThe next meeting of the execution team will be on 6-16-2022\n\n\nR Adowtion Series Webinar\nThe next R Consortium R Adoption series webinar will feature the work of the Submissions Working group The tentative agenda for the 2022 July R Adoption webinar is:\n\nTentative date: July 14\nMeeting length: 1.5 hr\nOpening (5min) - Coline, R consortium/Roche\nPresentation: Achieving Regulatory Approval Using R (20min) Tae Hyun Jung, FDA\nPresentation: Review experience of the R consortium R submission pilot 1 (20min) Hye Soo Cho, FDA\nPanel discussion (45min)\nModerator: Ning Leng, R consortium/Roche\nPanelists: Paul Schuette, Hye Soo Cho, and Tae Hyun Jung\n\n\n\nPilot 3\nJBR asked the group to begin thinking about Pilot 3. He noted that we had been thinking about using container technology in a submission, but the WG has not completed its investigation into container technology and the FDA does not appear to be ready for such a submission.\nTad suggested that questions about the content of a Pilot 3 submission would be appropriate for the panel discussion of the upcoming webinar.\n\n\nJapan Submission\nTad and his colleagues have had a paper accepted for the upcoming DIA Conference.\n\n\nChina Submission\nNo update.\n\n\nGeneral Discussion\nThe group then updated the project kanban board moving the shiny documentation to the “In Progress” column.\nThe discussion then turned towards considering the topic of HTA, Health Technology Assessment submissions that was considered in our previous meeting. We are only at the beginning stages and need discuss which European agency we would like to target and what we could bring to the HTA process. As was noted at our previous meeting, NICE in the U.K. and IQWIG in Germany are the primary candidates.\nAction HTA submissions will be a topic for the July Meeting. Tad Lewandowski will ask his colleague Christian Buehrer to speak about Roche’s efforts in this area.\nGregory Chen noted that several members of the WG have expressed in interest in HTA submissions. He also suggested that it would be very helpful to involve experts in this area to assist us.\nAction Gregory agreed to take the lead on compiling a list of experts whose participation could help the working group.\nAction Once the list is available, JBR agreed to contact people on the list to seek their participation.\nThe next meeting of the WG will be at 9AM Pacific Time, on Friday July 1, 2022." }, { - "objectID": "minutes/2024-03-01/index.html#user-2024", - "href": "minutes/2024-03-01/index.html#user-2024", - "title": "Minutes 2024-03-01", - "section": "UseR! 2024", - "text": "UseR! 2024\nThe group decided to submit an abstract for useR!2024 which will be held from July 8 to 11 in Salzburg, Austria. the deadline for the CFP is Sunday, 10 March at 11:59 PM CET (UTC+1)\nAction:\nEric and Ning will draft the abstract." + "objectID": "minutes/2024-05-03/index.html", + "href": "minutes/2024-05-03/index.html", + "title": "Minutes 2024-05-03", + "section": "", + "text": "View Attendee List\n\n\n\n\n\n\nEric Nantz (Eli Lilly)\nHeidi Curinckx (Johnson & Johnson)\nHyeSoo Cho (FDA)\nJizu Zhi (FDA)\nJoel Laxamana (Roche/Genentech)\nJoseph Rickert (R Consortium)\nNan Xiao (Merck)\nNing Leng (Roche/Genentech)\nPaul Schuette (FDA)\nRobert Devine (Johnson & Johnson)\nSam Parmar (Pfizer)\nLovemore Gakava\nYoun Kyeong Chang\nThe meeting was recorded and the video is available" }, { - "objectID": "minutes/2024-03-01/index.html#pilot-4-update", - "href": "minutes/2024-03-01/index.html#pilot-4-update", - "title": "Minutes 2024-03-01", - "section": "Pilot 4 update", - "text": "Pilot 4 update\nAt 38:38 into the video of the meeting, Eric previews the Pilot 4 WebAssembly (Wasm) submission. To be compatible with Wasm, the submission is being built with the Rhino framework for shiny which is different from what was used in Pilot 2 but is functionally equivalent. The screen capture below references the compiling the WebR Wasm submission with shinylive.\n After the build it is necessary to launch a webserver process on your your local setup. The Wasm version of the Shiny app reproduces the teal filters without using teal itself.\n The next step is to test the application on the container approximating the FDA Windows environment.\n\nImmediate Plans\nJoel’s team will continue working on Pilot 3 re-submission with the goal of picking a submission date at the April meeting." + "objectID": "minutes/2024-05-03/index.html#discussion-of-recently-revealed-r-vulnerability", + "href": "minutes/2024-05-03/index.html#discussion-of-recently-revealed-r-vulnerability", + "title": "Minutes 2024-05-03", + "section": "Discussion of Recently Revealed R Vulnerability", + "text": "Discussion of Recently Revealed R Vulnerability\n\nThe working group spent a few moments discussing the recently raveled vulnerability in R as reported in Dark Reading and other online sites and discussed in this infosec exchange.\nThe working group that the incident highlights the need for caution in accepting serialized objects just as one ought to be careful about clicking on any link from an untrusted source.\nIt was noted that our pilot submissions do not directly transmit data sets.\nJBR noted that he has heard the R Foundation is working on an official statement about the incident and that the R Consortium will draw attention to it when it is available.\nThe working group agreed that the incident should be viewed as an “overdue wake up call” and.\nJBR suggested that this might we a good time to see if we could attract R users with security expertise to the R Consortium.\nEric suggested Bob Rudis and and posted this link to a relevant post.\n\nAction: JBR to investigate the possibility of a security focused working group." }, { - "objectID": "minutes/2024-03-01/index.html#the-submission-environmnt-setup", - "href": "minutes/2024-03-01/index.html#the-submission-environmnt-setup", - "title": "Minutes 2024-03-01", - "section": "The Submission Environmnt Setup", - "text": "The Submission Environmnt Setup\nSetting up the submission environment is a manual process. The WG would like to automate at lest some of this process to ease the burden of setup and improve repeatability. It would be nice to have a GitHub action workflow that uses containers and runs on Azure. This will be a topic for the next meeting.\nAction: JBR will promote this task and try to find a company willing to work on it." + "objectID": "minutes/2024-05-03/index.html#pilot-3", + "href": "minutes/2024-05-03/index.html#pilot-3", + "title": "Minutes 2024-05-03", + "section": "Pilot 3", + "text": "Pilot 3\n\nPilot 3 was resubmitted on April 19, 2024 under BLA application number 111111 sequence 0007\nHyeSoo confirmed receipt by the FDA and performed a preliminary analysis.\nHyeSoo’s update begins at 10 minutes, 30 seconds into the video\nHer initial check did not reveal any major issues, but she did have a few minor issues mostly relating to the zip file and file names.\nHyeSoo shared two solutions to the error depicted in the screen capture below.\n\n * There was also an inconsistency with a file name in the submission and the name in the ADRG. * A solution might be to rename the file after submission. * The FDA target date to wrap up the review is early July. * This would enable Ning to include the news the the useR! presentation." }, { - "objectID": "minutes/2024-03-01/index.html#swissmedic-wg", - "href": "minutes/2024-03-01/index.html#swissmedic-wg", - "title": "Minutes 2024-03-01", - "section": "Swissmedic WG", - "text": "Swissmedic WG\nJBR asked the WG for help in identifying Europe-based Pharma employees who might be interested in starting a new working group focused on Swissmedic.\nAction: Ning will open an issue on this and tag JBR and Gregory." + "objectID": "minutes/2024-05-03/index.html#pilot-4", + "href": "minutes/2024-05-03/index.html#pilot-4", + "title": "Minutes 2024-05-03", + "section": "Pilot 4", + "text": "Pilot 4\n\nEric Nantz begins presenting his update on Pilot 4 at 32:35 into the video.\nThe ADRG for Pilot 4 which is almost complete.\nThe following screen capture shows the commands starting wasm in Eric’s Windows VM.\n\n\n\nThe 10GB threshold on etcd gateway mostly to guarantee transfer on first try.\nPilot 4 transfer is approximately 800 MB\nDecision mate to try two ways of building wasm app\nPrebuilt before transfer\nBuilt by FDA after transfer\nSpecified versions of R and RStudio IDE need to be pre-installed.\nThe target for submission is late June or early July after HyeSoo has sent her evaluation of Pilot 3 off for document clearance\nIt might be possible to also submit the docker version of Pilot 4\nPaul will investigate whether docker desktop or docker runtime is possible or preferable." }, { - "objectID": "minutes/2024-03-01/index.html#next-meeting", - "href": "minutes/2024-03-01/index.html#next-meeting", - "title": "Minutes 2024-03-01", - "section": "Next Meeting", - "text": "Next Meeting\nThe next meeting of the working group will be on Friday, April 5, 2024 at 9AM PST." + "objectID": "minutes/2024-05-03/index.html#adrg-standard", + "href": "minutes/2024-05-03/index.html#adrg-standard", + "title": "Minutes 2024-05-03", + "section": "ADRG Standard", + "text": "ADRG Standard\n\nThere is a proposal that the RC investigate setting up a working group for drafting an ADRG standard for R.\nWe will open up an issue o the submissions-wg repository to capture ideas members may want to contribute and then discuss the proposal at our next meeting." }, { - "objectID": "minutes/2022-02-04/index.html", - "href": "minutes/2022-02-04/index.html", - "title": "Minutes 2022-02-04", - "section": "", - "text": "View Attendee List\n\n\n\n\n\n\n“Phil Bowsher - RStudio”\n“Heidi Curinckx - Johnson & Johnson”\n“Graeme Hickey - BD”\n“Ellis Hughes - GSK”\n“Emily Nguyen - FDA”\n“Jiang Xu - FDA”\n“Steven Hassendinckx”\n“Ning Leng - Genentech”\n“Joseph Rickert - R Consortium”\n“Paul Schuette - FDA”\n“Nan Xiao - Merck”\n“Renping Zhang - FDA”\n“Yilong Zhang - Merck”\n“Tadeusz Lewandowski - Roche”\n“Michael Mayer - RStudio”\n“Eric Nantz - Lilly”\n“Xin Qiu - Johnson & Johnson”\n“CG Wang”\n“Michael Blanks - Beigene”\n“Gregory Chem - MSD”\n“Hey Soo Choo - FDA”\n“Bob Engle - Biogen”\n“Bella Feng - EQRx”\n“Miram Fossati - Merck”\n“Ryan Johnson - RStudio”\n“Christopher Kania - Biogen”\n“Shannon Lewis - Beigene”\n“Eli Miller - Atorus”\n“Jonathan Tisack - Beigene”\n“Shiva Kalyan Voruganti”\n“Hong Yan - Regeneron”\n“Patruchi”\n\n\n\n\nThe meeting was recorded and the video (Passcode: &nET4J?I) is available.\nJR began the meeting and asked NL to give an overview of the GitHub repositories for the Submissions WG. Every submission will have two repositories: a development repo and a repo that follows the FDA ECTD structure that contains the files that will go through the gateway.\n\nsubmissions-wg is he umbrella repo that contains the kanban board for the project.\nsubmissions-pilot1 is the development repository for the Pilot 1 submission\nsubmission-pilot1-to-fda contains the only the files that will go to the FDA\nsubmissions-pilot2 is the development repo for Pilot 2\n[https://github.com/RConsortium/submissions-pilot2]\n\nThe group then summarized the present status of the project. The Pilot 1 submission of last year was mostly successful but the FDA response flagged a couple of problem areas: * An apparent but the resulted in column labels being switched * An unexplained rounding discrepancy in a p-value may be due to different operating systems. * Several good practice issues to address\nHSC who helped to conduct the FDA review of the Pilot 1 submission offered to share the code that flagged the rounding error. She will enter it as an issue on the submissions repo.\nThe Pilot 1 team has been working on the Pilot 1 resubmission. The team will will review the FDA code and test it on multiple operating systems. They expect to be able to resubmit in a couple of weeks. NL asked if HSC could look over the new code before they do so. Assuming that the resubmission goes well the group will prepare a blog for posting on the RC blog.\nNL then reviewed plans of the Pilot 2 shiny submission. It is envisioned as a simple four tab Shiny app that contains the same analyses as the previous submission. The plan is to use the Roche teal framework because of its filtering structure.\nYZ then outlined work required to complete the Pilot 2 work and identified three dependencies:\n\nteal must become open source\nThe scope of Pilot 2 needs to be clarified\nA template needs to be developed for submission documentation that includes a Shiny app.\n\nYZ recommended that a separate Pilot 2 documentation team be formed to work on the Shiny documentation in parallel with the code development for Pilot 2.\nEN said that he had experience preparing this sort of documentation and agreed to lead the documentation task.\nJR asked when teal would become open source and whether the fact that it is not now open source prohibiting other companies from contributing to the project. TL responded that project to open source teal is currently with the Roche lawyers and that he expects it will be complete within three months. No one present believed that not currently having teal as open source code was prohibiting participation. Everyone will be able to run the Shiny app from a public website. EN noted that work on infrastructure can proceed in parallel.\nThe team working on Pilot 2 said that a submission in Q2 is feasible.\nCurrently there are not plans for multiple Pilot 2 submissions. However, it is likely that we would want to have a submission in the future that includes a more complicated Shiny app. JR noted that it would be optimal if the FDA could provide guidance on what features they would like to see in a more robust Shiny app.\nMoving beyond Shiny JR asked if by the end of the year we would be looking a submission based on container technology. EN remarked that that is the direction the group would like to see but since Docker is not suitable (because of licensing issues) it will be necessary to research alternative container technology.\nJR noted that having 29 people in the meeting indicated that there was considerable industry interest in the work being done and whether it would be possible to recruit a team to do the research for long range projects. He asked group members who are not involved in immediate work to get involved in long term planning. EN noted that we definitely need to help from the regulatory side to help effect any changes that would have to be made to make use of container technology.\nThe discussion then turned to the possibility of making a submission to CDE the Chinese health authority. (See issue #62 ) They are trying their own submissions gateway. They have shared validation software with Roche that could check a submission. NL suggested that we undertake an effort to see if we could validate a test submission using the Chinese supplied software. If that worked the only additional work to be done to make a viable submission to the CDE would be to translate the documentation into Chinese.\nNL asked if anyone has contacts with the CDE that could review a test submission from the Submissions WG. JR asked EN if she could check with PS about possible FDA contacts with the CDE.\nBF noted that her company, EQRx, has the opposite problem. They have had a compound approved by the CEA and now want to submit it to the FDA. She noted that there are high level regulations about the transfer of data between China and the FDA. The CDE has an HGR application that must be approved by the Human Genetic Resources Agency for China. HY offered that she has some experience dealing with the CDE, having done two or three submissions to the CED in the past when she worked for Novartis. At that time the CDE accepted the FDA package.\nThe discussion they turned to other countries HY noted that she is working on a submission to the Japanese PMDA which the group aggreed is more strict than the CDE an offered to look for a contact there.\nYL noted that the German authorities have strict requirements about the table formats.\nJR asked if there is there is a European authority that we should have on our radar. Apparently, the EMA does not presently require a data submission, but that may be changing. TL noted that they have had a proof of concept sharing data with the EMA.\nYL also raised the possibility of following the PHUSE ADGR template. He suggested that we contact PHUSE and ask if they would be willing to update the template so that it does not specify SAS data sets. JR agreed to look for a contact within PHUSE. We would want a language agnostic template.\nNL noted that this would be a good time to revisit our effort to develop suggested language for section 14 (issue #38).\nJR suggested that we need some high level planning document to capture all of the ideas presented.\nAt 47:10 in the video NL explains the contents of the Submission WG GI Hub sites.\n\nSome useful links from the chat box\nR Consortium GitHub sites: https://github.com/RConsortium/\nWG web page: https://rconsortium.github.io/submissions-wg/\nTracker for the pilot1 submission: https://github.com/RConsortium/submissions-pilot1-to-fda/issues\nhttps://github.com/RConsortium/submissions-wg/issues/38\nIssue filed for pilot 2 documentation : https://github.com/RConsortium/submissions-wg/issues/63" + "objectID": "minutes/2024-05-03/index.html#recording-chat-file-contents", + "href": "minutes/2024-05-03/index.html#recording-chat-file-contents", + "title": "Minutes 2024-05-03", + "section": "Recording Chat File Contents", + "text": "Recording Chat File Contents\n\n00:08:01 Sam Parmar: Reacted to “https://infosec.exch…” with 👍🏽\n00:10:01 Eric Nantz: This is another balanced take https://aitap.github.io/2024/05/02/unserialize.html\n00:10:06 Sam Parmar: Reacted to “This is another bala…” with 👍🏽\n00:11:44 Sam Parmar: The Python pickle modules has a very similar situation. https://docs.python.org/3/library/pickle.html\n00:12:04 Sam Parmar: That blog post Eric linked mentions it.\n00:17:11 Eric Nantz: https://rud.is/b/2024/05/03/cve-2024-27322-should-never-have-been-assigned-and-r-data-files-are-still-super-risky-even-in-r-4-4-0/\n00:17:15 Sam Parmar: Reacted to “https://rud.is/b/202…” with 👍🏽\n00:33:52 laxamanj: See Note from Pilot 1 submission : https://github.com/RConsortium/submissions-pilot1-to-fda/blob/main/m1/us/report-tlf.pdf\n00:40:28 Eric Nantz: Pilot 4 Readme: https://github.com/RConsortium/submissions-pilot4-webR\nPreview version of the Pilot 4 Analysis Data Reviewer Guide (ADRG):\nHTML Format: https://rpodcast.quarto.pub/pilot4-webassembly-adrg/\nPDF Format: https://rsubmission-draft.us-east-1.linodeobjects.com/adrg-quarto-pdf.pdf\n00:52:13 Sam Parmar: Hi Eric. Did we run mention this issue? https://github.com/RConsortium/submissions-pilot4/issues/5" }, { - "objectID": "minutes/2022-11-04/index.html", - "href": "minutes/2022-11-04/index.html", - "title": "Minutes 2022-11-04", - "section": "", - "text": "View Attendee List\n\n\n\n\n\n\nBob Engle (Biogen)\nEllis Hughes (GSK)\nEric Nantz (Eli Lilly)\nGregory Chen (MSD)\nHeng Wang (Roche/Genentech)\nHonghong Zhou (Moderna)\nHyeSoo Cho (FDA)\nJizu Zhi (FDA)\nJoel Laxamana (Roche/Genentech)\nJoseph Rickert (R Consortium)\nLei Zhao (Roche/Genentech)\nNan Xiao (Merck)\nNing Leng (Roche/Genentech)\nPaul Schuette (FDA)\nRenping Zhang (Johnson & Johnson)\nRobert Devine (Johnson & Johnson)\nSaghir Bashir (Argenx)\nStephanie Lussier (Moderna)\nTadeusz Lewandowski (Roche/Genentech)\nYilong Zhang (Meta)\nYiwen Luo (Merck)\nYutong Liu (Moderna)\n\n\n\n\n\nThe video is available on the R Consortium YouTube Channel\nThe meeting began with EN summarizing his understanding of the comments made by PS about his preliminary look at the Pilot 2 submission package.\nThe following is a summary of Paul’s comments which were made in a email exchange with the workgroup members on 10-27-22:\n\nPaul has management approval to proceed with Phase 2 of the pilot, with the proviso that the Demographic, Primary and Efficacy Tables are static.\nThere is a minor error in the app: the low dose and high dose column settings reversed.\nThe efficacy table is slightly misleading as it currently stands. Suggest that the text for the first row read “Study Drug (High Dose)” or similar.\nSuggest an additional table: “Subjects Remaining in the Study” showing how dropouts proceed. (See Paul’s email of 10-27-22 for details) This might show how exploratory analysis might add value over the prespecified\nThe number of decimal places displayed in the demographic table isn’t always the same as in pilot 1.\nSuggest that the model specification information be included with the efficacy table rather than left to the app information.\n\nWe would like the app to be able to serve as a model for future submissions.\n\nEric stated that the updates appear to be relatively minor and would not be difficult to accomplish.\nThe submission team agreed to target 11-18-2022 as the target submission date.\nAction: JBR to put a 9AM 11-18-2022 on the calendar for the submission.\nJBR asked Paul to describe the boundary between a useful amount and too much interactivity in a shiny submissions app. Paul replied that it a way to think about it would be the difference between exploratory and inferential analysis. The problem with inferential analysis is the usual problem with p-values, subgroups and cherry picking. Inferential analysis is not the way to go. A Kaplan-Meier curve would be considered an exploratory safety analysis.\nWhen asked if the guidance on interactivity was likely to stand for some time or change with familiarity Paul replied that it was his personal opinion that since it is consistent with the ASA Statement on p-values it will probably stand.\nPaul also remarked that interactivity facilitating pre-specified analyses would probably be fine.\nThe following links may be helpful with understanding potential problems with on subgroup analyses:\n\nAlosh et al. (2015)\nAlosh et al. (2016)\n\nJoel Laxamana gave an update on the Pilot 3 effort:\n\nThe kickoff meeting for the team was held this past Wednesday\nThere are 13 people on the team\nThe goal of Pilot 3 is to duplicate Pilot 1 but also generate the ADaM data sets used for the TLGs in Pilot 1\nThe idea is to start with the STDM and show the traceability to ADaM\nPilot 3 will use the admiral package along with tidyverse packages.\n\nAction: Joel will add this explanatory material to the Pilot 3 GitHub repo.\nAction: Joel will send a list of Pilot 3 team members to be added to the invitation list for this meeting.\nAction: The Pilot 3 team will submit a written proposal to the FDA describing the process of unpacking the submission and setting up for analysis. The target date is to have this proposal ready for the 12-02-2022 Submissions WG meeting.\nLei Zhao asked if it would be a problem submitting data in SAS in doing the analysis in R. In general there is no problem, however the FDA suggests using a limited number of tools and using standard tools to do any translations between formats. The FDA prefers using scripted languages as opposed to using a GUI.\nNing will be presented at the R/Pharma conference on Wednesday, November 9, 2022 at 11AM Eastern Time. The next meeting of the regular meeting of the group will be at 9AM Pacific Time on Friday, December 2, 2022." + "objectID": "minutes/2024-05-03/index.html#next-meeting", + "href": "minutes/2024-05-03/index.html#next-meeting", + "title": "Minutes 2024-05-03", + "section": "Next Meeting", + "text": "Next Meeting\nThe next meeting of the working group will be at 9AM Pacific Time on Friday June 7, 2024." }, { - "objectID": "minutes/2022-01-07/index.html", - "href": "minutes/2022-01-07/index.html", - "title": "Minutes 2022-01-07", + "objectID": "minutes/2023-08-04/index.html", + "href": "minutes/2023-08-04/index.html", + "title": "Minutes 2023-08-04", "section": "", - "text": "View Attendee List\n\n\n\n\n\n\n“Phil Bowsher - RStudio”\n“Heidi Curinckx - Johnson & Johnson”\n“Graeme Hickey - BD”\n“Ellis Hughes - GSK”\n“Emily Nguyen - FDA”\n“Jiang Xu - FDA”\n“Steven Hassendinckx”\n“Ning Leng - Genentech”\n“Joseph Rickert - R Consortium”\n“Paul Schuette - FDA”\n“Nan Xiao - Merck”\n“Renping Zhang - FDA”\n“Yilong Zhang - Merck”\n“Tadeusz Lewandowski - Roche”\n“Michael Mayer - RStudio”\n“Eric Nantz - Lilly”\n“Xin Qiu”\n“CG Wang”\n\n\n\n\nThe meeting was recorded and the video is available with Passcode: g?xb.9fs\nNing Leng began the meeting by providing a brief summary of recent submission. We received written feedback from the FDA which is available in the submissions repository here. There were a few findings with the pilot:\n\nA mislableed treatment arm (This is a potential bug)\nA rounding issue\nTable fomatting\n\nNL noted that our execution team was not able to recreate the rounding issue, and asked PS is it would be possible to for us to look at the FDA code. This is possible, but needs to be cleared with management and may take a couple of weeks,\nNing and the other members of the submission execution team are looking into these and hope to be able to submit a follow up to Pilot 1 in several weeks. Ning asked if the FDA would be willing to review the resubmission of Pilot 1. PS said that this would be fine.\nThe discussion then moved to the contents of Pilot 2. PS noted that with submitting .R files we already met some of the goals we had been planning for Pilot 2.\nTo begin the discussion JR asked: what kinds of things have been considered difficult to do in submissions in the past and what could we do that would be impressive from the FDA’s point of view?\nPS suggested package versioning and archival issues\nNL suggested four topics that have come up in previous discussions.\n\nPackage versioning\nUsing Docker\nAlternative data formats to sas7bdat\nShiny\n\nEN agreed that these were the top issues, and noted that using a container such as Docker would also solve the package versioning.\nPS remarked that doing anything with data formatting is unlikely at this time. Two recent pilots failed to come up with an alternative. This is “not the hill to die on” right now. It is probably an issue that is worthy of broader discussion with other groups such as ASA, DIA, or PHUSE. PS suggested looping in Heather Crandall and OBI, the Office of Business Informatics.\nPS also noted that Docker has made changes to licensing so that FDA is not able to play with local installations of Docker. EN said that he was aware of these issues and suggested alternatives such as podman which he believes to be the first candidate to investigate. PS stated that any container technology would have to be approved by IT. He also noted that the FDA is currently using an obsolete version of Docker, and that upgrading to a newer version would have to go through the FDA approval process. Also, the FDA security team will not let containers have access to the hard drive. The group concurred that since getting Docker approved would not be any easier than podman the group should explore this new technology. EN offered to take the lead on this and enter the task into the Kanban board.\nPS suggested that since we have just shown that we can get a package through the gateway, the next step might be to turn a shiny app into a package and pass it through the gateway. EN confirmed that this is indeed possible and noted that the golem package can do this and deploy the shiny app locally without having to go to a server.\nYZ noted that he has seen several linkedin posts about using Shiny for submissions and asked if that was happening in this group. PB stated that this Shiny submissions effort is being run by the R/Pharma group. They are planning to start holding monthly meeting, the first being at the end of January. R/Pharma wants to focus on the technical issues.\nThe group agreed that the path forward with Shiny as a package is much more straightforward than using containers, and suggested that we settle on Shiny for Pilot 2 and Containers for Pilot 3.\nThe discussion then turned on which Shiny app we should select. TD suggested the teal package that Roche is working on and noted that Roche is planning to make this open source. The group agreed that the source code of any Shiny package submitted should be open source.\nAt 30:03 into the video, TL demonstrated the teal package. After the demo, the group discussed the benefits of submitting a complicated package like teal which has several interesting features versus a simple app that meets the basic requirements. PS noted that ideally we would want to launch server from a local PC and not touch a server. To do otherwise would require the FDA to involve a special contractor and funding. The group decided to use a simple app and NL suggested wrapping the Pilot 1 modules into a Shiny app.\nAt 46:15 into the video, TL demonstrates calling different packages from a Shiny app.\nEN agreed to open up a second repo for development of Pilot 2. We will keep use the same setup as Pilot 1 and have the kanban board on the main submissions repo point to the Pilot 2 repo.\nJR said that he would follow up with PHUSE about work they may be doing on the formatting issue.\nNL asked about accumulus synergy, an FDA and cross industry looking at cloud solutions. Would there be a way to connect our container effort with accumulus? The group suggested searching for a contact.\nJR noted that before the next submission of Pilot 1 we must write to the FDA to reopen the gateway.\nThe next meeting of the working group will be at 9AM Pacific Time Friday, February 4, 2022." + "text": "View Attendee List\n\n\n\n\n\n\nBen Straub (GSK)\nLi Eva\nChristopher Kania (Biogen)\nEric Nantz (Eli Lilly)\nHyeSoo Cho (FDA)\nJizu Zhi (FDA)\nJoel Laxamana (Roche/Genentech)\nJoseph Rickert (R Consortium)\nNan Xiao (Merck)\nNing Leng (Roche/Genentech)\nPaul Schuette (FDA)\nSam Parmar (Pfizer)\nShannon Lewis (BeiGene)\nStephanie Lussier (Moderna)" }, { - "objectID": "minutes/2021-05-07/index.html", - "href": "minutes/2021-05-07/index.html", - "title": "Minutes 2021-05-07", - "section": "", - "text": "View Attendee List\n\n\n\n\n\n\n“Bryant Chen - FDA”\n“Bob Engle”\n“Steven Hasendinckx J&J”\n“Doug Kelkhoff - Genentech”\n“Ning Leng - Genentech”\n“Eric Nantz - Lilly”\n“Joseph Rickert - R Consortium”\n“Paul Schuette - FDA”\n“Mike Stackhouse - Atorus Research”\n“Adrian Waddell - Roche”\n“Nan Xiao - Merck”\n“Yilong Zhang - Merck”\n\n\n\n\n\nRecording\nThe meeting was recorded and the video is available at the link given below. Time stamps in the Minutes refer to the video.\n\n\nMinutes\nJoseph Rickert opened the meeting at 9AM Pacific Time and told the group that Mike Stackhouse has revised the document for a pilot submission which is in the document folder of the GitHub repo. He asked Mike to give an overview.\n1:10 Mike’s Overview: The Submissions Working Group should make the opportunity to test out the pkglite package and try to get a pilot submission through the eCTD gateway. The objective would be to determine if an FDA reviewer would be able to receive and consume the content. This effort would be a discovery process exposing unanticipated problems in getting an R submission through the gateway and help to identify difficulties an FDA consumer would have in replicating the outputs of the pilot.\nMike stated that having a concrete example of pushing an R submission through the gateway would be “momentous”.\n6:37 Joe asks Paul Schuette if he agrees with Mike’s assessment of the benefits of the pilot. Paul affirms that it would be helpful and suggest using a simulated data set.\n7:55 Joe asks Paul if special preparation would have to happen on the receiving side. Paul replies that it would depend on the processes and procedures of gateway, and notes that in the past the authorities have asked for submissions by DVD and mail (This came up last year with respect to submitting University COVID tests.)\n11:03 Paul recommends putting in a formal request to involve additional agency reviewers. Mike suggests that submitting through Phuse would have some advantages since Phuse has a structured relationship with the FDA.\n12:53 Based on previous experience, Paul states that his is not certain about the efficacy of the Phuse relationship, but that he does not have serious objections\n15:06 Paul raises the possibility that the R Consortium could sponsor the pilot. Doug Kelkhoff, Yilong Zhang and others endorse this idea.\nAdrian Waddell asks how difficult is it to make a submission? Paul replies that he is not sure, but adds that to his knowledge at least one foundation has made a submission in the past. He advises we would have to reach out to group that manages gateway and EDR, and remarks that the R Consortium may have resource issues that pharma company does not have.\n17:37 Adrian alternative:\n\nSplit out the data and analysis code which need to be secure and go through gateway process.\nPut the code that does not involve patient level data on a public Github repository and devise a secure way to give the agency access.\n\n19:35 Paul describes a similar process he and Eric went through with a Lilly pilot where Paul had access to a Lilly Github site for 8 hours. This was a process that agency was able to handle with Eric’s help, but it was a one-off effort as part of CID pilot and not a typical submission. He speculates that the process would probably not be allowed as part of standard submission package.\n26:09 Mike brings the conversation back to logistics of getting a submission number to get the pilot process started.\n27:24 Joe asks if it is possible for more than one company to make joint submission and Doug clarifies this to mean have multiple companies co-sponsor a submission. He that the word “Sponsor” has a technical meaning to the FDA and that the system is set up for sponsors to be a company. The group agrees that the ideal would be to have R Consortium be the surrogate sponsor of the pilot.\n28:48 Paul suggests that we assess the possibility of having the R Consortium sponsor by reaching out to Ethan Chen who heads up the Division of Data Management Services and Solutions. Doug suggests that we invite Ethan, or someone designated by him to our next meeting.\nPaul notes that the invitation should be a formal process and suggests that as the representative of the R Consortium Joe write to Ethan to ask his group to participate in the process of planning for a pilot submission. Paul suggests that the letter could reference him and that the content of the letter emphasize that our group is part of an industry effort to help enhance and modernize submission tools. We are independent of, but in line with the recent Transcelerate MSA framework and the work being done by the R Validation Hub. Both of these efforts provide some justification as to why companies and consortia are interested the submissions process.\n34:37 Joe agrees write the email letter. Doug, Eric and other agree to help with drafting it.\n40:40 a discussion about whether approvals need to be obtained from the individual pharmaceutical companies\nAdrian points out that we would want to be able to try multiple approaches, and Paul indicates that an advantage of having the R Consortium sponsor would be to have multiple updates on the same submission number. It can sometimes take some companies multiple efforts to get something through the gateway\n46:53 Adrian asks when we make a solution how does the analysis code access the data? Paul replies that the standard is to have an M5 folder to hold CDISC tabular data and analysis data - code can be in separate folder or along with analysis data sets.\n51:00 Adrian describes the main goal to give health authorities something that they can easily use themselves.\n51:30 states the measure of success : Deliver something like like the CDISC package through eTCD and have and FDA reviewer recreate and install packages and reproduce the results\n54:41 Doug advises that the letter be general with no technical detail stating the R Consortium’s interest in being a sponsor and asking for agency participation.\nAction item Joe to draft letter and place it in the documents folder of the submissions repo by Tuesday of next week. The team will review and comment.\nThe video recording of the meeting is available here Passcode: Gb#E@4$S" + "objectID": "minutes/2023-08-04/index.html#minutes", + "href": "minutes/2023-08-04/index.html#minutes", + "title": "Minutes 2023-08-04", + "section": "Minutes", + "text": "Minutes\nThe meeting was recorded and the video is available.\n\nPilot 2\n\nHyeSoo Cho reported that she is working with the Pilot 2 re-submission and that it looks good.\nHyeSoo expects that the final on this pilot submission will be available at the end of August.\nEveryone recognized and thanked Eric Nantz for the sustained and last-minute efforts to get the submission out.\n\n\n\nPilot 3\n\nPaul Schuette brought the attention of the group to section 4.i.2.10 of the Study Data Technical Conformance Guide - Technical Specification Document and noted that .r and .zip files are listed as acceptable file formats for submissions.\nAfter some discussion, the WG decided not to use pkglite to wrap the R code as has been done in previous submissions, but to use .r files for the code. (Note that the FDA is unable to use .R internally.)\nPaul noted that the FDA desires submission materials to be applicable for at least six years after submission. This triggered a discussion about possibility of using .zip files to transmit the proprietary packages, instead of pulling them from public GitHub repos as been done so far.\nIn the end, the WG decided to stick with using GitHub repos for Pilot 3 as there is currently no apparent advantage testing the .zip file method at this time.\nJoel Laxama reported that preparations for Pilot 3 are going well, and that a submission using .r files could be made in early September.\nThe WG thought it best to wait for the report of Pilot 2 before submitting Pilot 3.\n\n\n\nPilot 4\n\nEric reported that thanks to the contributions form the Appsilon team significant progress has been made on using both mechanisms for packaging R submissions: Containers and Webassembly.\nAppsilon has a prototype submission using Podman container technology working and has confirmed that it does not cause files to be written to the hard-drive.\nEric and the Appsilon engineers also have a very preliminary prototype of using Webassembly to wrap a small Shiny app working.\nPosit engineers have contributed webr expertise.\nEric is optimistic about having Pilot submissions based on at least one, and possibly both, of these technologies ready by the end of the year.\n\nAction\n\nPaul will confer with the proper FDA authorities to determine what preparations need to be undertaken by the FDA to use the Podman containers.\nEric will invite an Appsilon representative to come to a future meeting of this working group\n\n\n\nJuly 21 San Jose State R Foundation Event\nThe R Foundation SummeR Bay Area R Meetup was held at San Jose State University on July 21. Ning Leng reports that:\n\nThe 50 plus attendees indicated that quite a few Bay Area companies are moving towards using R in preclinical and genomics research.\nRepresentatives from several small CROs attended the meeting.\nR Consortium recognition was not good among this group.\n\nAction\n\nJBR and Ning to discuss what can be done to promote the RC.\n\n\n\nSpeaking Opportunities\n\nEric will submit an abstract to speak about Pilot 3 and Pilot 4 at the R/Pharma virtual conference to be held in on October 24 - 26.\nPaul will be presenting at both at the PHUSE/FDA CSS 2023 conference on September 18 -20 and the ASA Biopharmaaceutical Section Regulatory-Industry statistics Workshop to be held in Rockville, MD on September 27 - 29 and intends to use the activities of this working group as a case study.\nNing suggests that it would be very nice if the RC could hold and R Adoption Webinar in the November time frame to describe the Pilot 2 and Pilot 3 submissions.\n\nAction:\n\nPaul will check with FDA authorities to see whether it is appropriate for the R Consortium to publicize his speaking opportunities on social media.\nJBR will work with the RC Community development committee to make preparations for the promoting the speaking activities and setting up the webinar.\n\nThe next meeting of the Submissions working group will be at 9AM PST on Friday, September 1st." }, { - "objectID": "minutes/2021-12-03/index.html", - "href": "minutes/2021-12-03/index.html", - "title": "Minutes 2021-12-03", + "objectID": "minutes/2021-03-05/index.html", + "href": "minutes/2021-03-05/index.html", + "title": "Minutes 2021-03-05", "section": "", - "text": "View Attendee List\n\n\n\n\n\n\n“Phil Bowsher - RStudio”\n“Hye Soo Cho - FDA”\n“Heidi Curinckx - Johnson & Johnson”\n“Miriam Fossati - Merck”\n“Ellis Hughes - GSK”\n“Maria Matilde Kam - FDA”\n“Emily Nguyen - FDA”\n“Jiang Xu - FDA”\n“Steven Hassendinckx”\n“Ning Leng - Genentech”\n“Joseph Rickert - R Consortium”\n“Paul Schuette - FDA”\n“Adrian Waddell - Roche”\n“Nan Xiao - Merck”\n“Hong Yaan - Regeneron”\n“Renping Zhang - FDA”\n“Yilong Zhang - Merck”\n“Jizu Zhi - FDA”\n\n\n\n\nThe meeting was recorded and the video is available here Passcode: 0tA$D+ev\nJR Opened the meeting with the agenda to discuss the recent pilot submission through the FDA gateway and then discuss a request to have interested companies describe what they are currently doing with respect to FDA submissions in R.\nYZ reported that the submission went through the gateway, thanked all who participated and was looking forward to receiving feedback from the FDA.\nJR reported that there were still issues with employees from different companies using the RC portal. The current solution is to have people accessing the gateway on behalf of the RC use an R Consortium email address. JR wants to make sure that this is fine with the FDA.\nAt 6:37 into the video PS begins providing FDA feedback on the submission.\nThe initial findings were:\n\nThe submission was partially successful\nThe were no problems with the .R extensions\nThe FDA was unable to find the Pilot1wrappers package. However, the * * FDA analyst was able to generate tables\nThe FDA thinks there may have been a switch in the high bit vs. bit settings and asked the WG to check this.\nThe FDA analyst was able to retrieve the pilot1wrappers package from the Submission WG website, download the code and verify the results\nThe FDA noted that including a dependency chart showing the 2nd and 3rd order dependencies would be very helpful. If this were and actual submission, at least one IR request would have been generated.\n\nOn behalf of the WG, JR thanked the FDA team for making extra effort to retrieve the wrapper package and run the code.\nIn the subsequent discussion it was determined that the FDA analysts overlooked the instructions, buried in the ADRG, to unpack the pilot1wrappers from the file r0plg.txt. Once this was clarified HC, the FDA analyst, was able to execute the command and unpack the pilot1wrappers package. HY noted that in her experience, submissions with R code tend to be ad hoc, and that it is common to include a README file. The WG took note and agreed that it would be a good idea to include a README file that highlights the key steps, maybe by referring to the ADRG.\nNext, followed a discussion about the requested dependency chart tree diagram. PS noted that the importance of dependencies depends on the setting. When running from a standard machine, FDA analysts are able to pull packages from the internet. However, when running from one of their scientific enclaves high performance computing environments they must port in the packages. To illustrate the problem with dependencies HC showed the error messages generated by calling R packages previously installed on her machine, but which did not have the dependencies installed that are required to run the submission code.\nThe problem seems to be that every file in the submission needs the library calls. This problem needs to be addressed.\nHC also identified a problem of not having write permissions.\nThe temporary solution seems to be to copy the file into a temporary folder. This problem needs more thought.\nIt was agreed that the WG should produce a document about establishing the proper environment. AW suggests that there are two possible actions: 1. Copying to a local folder might clear up most of the problems 2. If not, the WG should look into environment reproducibility\nPS noted that the FDA does not need to run on a central server. This implies that we can assume FDA analysts running on their local environments for the near future.\nPS suggested having a pre-submission meeting explaining everything that is necessary to get everything installed and working.\nAW suggested that we set up the submission assuming that each file will be run from a fresh R session, and that perhaps we could run some tests to see if the environment is as is expected.\nNL asked about writing a blog post about the pilot submission. The WG agreed to write up the post and have PS and HC review.\nYL asked about redoing the submission. PS said indicated that is common practice.\nNL said that she and HC would like to schedule a separate meeting early next year to discuss where the various participating companies are in the process of making R submissions. Please let NL know if you are interested in participating.\nThe next meeting is set for 9:00 AM Pacific Time on Friday, January 7, 2022." + "text": "View Attendee List\n\n\n\n\n\n\n“Joseph Rickert - R Consortium”\n“Adrian Waddell - Roche”\n“Paul Schuette - FDA”\n“Bella Feng - EQRX”\n“Yilong Zhang - Merck”\n“Doug Kelkhoff - Genentech”\n“Mike Stackhouse - Atorus Research”\n“Nan Xiao - Merck”\n“Ning Leng - Genentech”\n“Steven Hasendinckx J&J”\n“Bryant Chen - FDA”\n“Ojesh Upadhyay - GSK”\n\n\n\n\nJoseph Rickert opened the meeting at 9AM Pacific Time and pointed to the agenda in the Discussion Section of the GitHub repo.\nAgenda: 9:00: Doug Kelkhoff - R Validation Hub infrastructure 9:05: Nan Xiao the R package pkglite which packs/unpacks multiple R packages into txt file is going to be used in an upcoming FDA pilot eCTD submission 9:30: Open discussion We will continue the discussion initiated by Paul Schuette last time about modifying the software section of the study data technical conformance guide\nDoug provided an overview of the R Validation Hub protect, pointed out areas of overlap with this working group and welcomed those interested to participate in the Validation Hub effort. Detailed information on the R Validation Hub project which is also organized as an R Consortium working group can be found here.\nNext, Nan Xiao of Merck gave an overview and demo of the R package pkglite which is expected to be up on CRAN soon.\nThe specific aims of the package are:\n\nAim 1: To provide a tool for packing and restoring R packages as plaintext assets that are easy to store, transfer, and review.\nAim 2: To provide a grammar for specifying the file packing scope that is functional, precise, and extendable.\nAim 3: To provide a standard for exchanging the packed asset that is unambiguous, human-friendly, and machine-readable.\n\nNan’s presentation can be found in the Document’s section of the R Consortium/submissions-wg GitHub repository.\nYilong stated that he hoped that our working group could collaborate on a pilot submission to the FDA. He prepared the following outline to be included in these minutes.\nGoal: prepare a open source dummy submission and submit to eCTD portal\nThe information below is to track potential high level action items. Individual issues can be created to track the progress later.\nData source: CDISC pilot submission\nR program for table listing and figure (TLFs): program\nGeneral action items:\n\nMake sure this use case is following CDISC terms of use\nIdentify TLFs in-scope for submission\n\nAction items for dummy submission package preparation:\n\nIdentify point of contact to initiate dummy submission request\nPrepare analysis results metadata\nPrepare step-by-step instruction to re-run analysis based on code in program folder and put in ADRG: link\nWrap-up submission package\n\nThose present all seemed to be enthusiastic about cooperating on the generating a dummy submission.\nNext, followed a lengthy discussion on the required process. Mike Stackhouse suggested that we work with PHUSE to suggest people who may be knowledgeable about past CDISC submissions. Paul Schuette recommended Zak Skrivanek.\nYilong Zhang mentioned that Merck intends to use this package as part of a pilot oncology submission in the near future. Bella mentioned that the FDA Oncology group had specified SAS.\nNing Leng of mentioned that Roche is preparing a rare disease submission for 2022.\nJoe Rickert asked the group: assuming the pkglite dummy submission is successful, how far the this would advance us towards the ultimate goal of an all R submission.\nWhile everyone was very excited about the pkglite all agreed with Doug Kelkhoff’s sober assessment that the industry would ultimately want a more “R idiomatic” solution that took advantage of R naming conventions and did not introduce special requirements for R package maintenance.\nMike Stackhouse noted that a successful pkglite submission would break down a significant barrier to R submissions, but that there were other hurdles. Nevertheless, he asserted that it would be a significant advance to be able to say here is “how” you can do an R submission.\nIt the few minutes that remained, Joe Rickert brought the groups attention to the copy of the word document containing the text of section 4.1.2.10 of the FDA document pertaining to software and asked everyone mark up the document to suggest ideal wording from the industry’s point of view.\nThe group agreed to met next on Friday April 1, at 9AM Pacific time.\nThe zoom recording of this meeting is available here (Passcode: d9N%+JWY)." }, { - "objectID": "minutes/2023-01-13/index.html", - "href": "minutes/2023-01-13/index.html", - "title": "Minutes 2023-01-13", + "objectID": "minutes/2024-02-02/index.html", + "href": "minutes/2024-02-02/index.html", + "title": "Minutes 2024-02-02", "section": "", - "text": "View Attendee List\n\n\n\n\n\n\nAndrew Borgman (Bristol Myers Squibb)\nBen Straub (GSK)\nBob Engle (Biogen)\nDoug Kelkhoff (Roche/Genentech)\nEric Nantz (Eli Lilly)\nHyeSoo Cho (FDA)\nJizu Zhi (FDA)\nJoel Laxamana (Roche/Genentech)\nKevin Kunzmann (Boehringer Ingelheim)\nLuke Schantz (R Consortium)\nPaul Schuette (FDA)\nPhil Bowsher (Posit)\nRyan Johnson (Posit)\nSean Healey (Pfizer)\nStephanie Lussier (Moderna)\nSteven Hasendinckx (Johnson & Johnson)\nTadeusz Lewandowski (Roche/Genentech)\n\n\n\n\n\n\nPilot 2 Update\n\nPaul Schuette confirms he was able to successfully run the Shiny application\nThey encountered a few messages that they ignored, as the app still ran successfully\nHyeSoo Cho followed the ADRG instructions and launched Shiny app, without major issues\nShe noticed minor issues around errors and warning messages. As part of her evaluation she tried launching the app in different machines to compare results. She saw some inconsistency between the environments, and they will report specific findings by next month (February)\n\n\n\nPilot 3 Update\n\nProposal was sent in early December for comments and feedback https://github.com/RConsortium/submissions-pilot3-adam/issues/37\nRunning into minor issues with using the same specifications and define settings as the original Pilot 1\nThey are not clear on the most up-to-date specifications to use for the AdAM creation, would like help from others\nThomas found a Phuse 2017 white paper on transport files for the next generation. This paper proposed new ways to convert the data before transfer\nAdditional ideas such as a proposal to use JSON format https://wiki.cdisc.org/display/ODM2/Dataset-JSON\nFDA is aware of the proposal, but it is not clear how far the proposal has gone\nStudy Data Technical Conformance Guide details the latest specs and what is acceptable in the gateway https://www.fda.gov/media/162867/download\nSponsors can use SAS version 8 of XPT if they choose, most sponsors are using version 5 from their experience\nOther pilots have explored alternative formats, but have not been satisfactory in their opinion\nIt is common to convert the XPT format to a more consumable format. For instance as sas7bdat in SAS or R objects inside R.\nPilot 3 will adhere to the current specifications\nBen recommended consulting with Sam Hume as a collaborate to push the effort along\nThe ectd gateway would need updating to accommodate json formats. That would require discussions with the E-data team in the FDA\n\n\n\nR Validation Hub intro to Repositories working group\n\nDoug Kelkhoff and Kevin Kunzmann led a an introduction to the mission and goals of the working group\nMission is to support a transparent cross-industry approach of maintaining a repo of R packages with evidence of their quality and assessment criteria\nRepo structure may resemble pieces of CRAN, R Universe . Still in the early stages of finding what is needed before working on the technical solutions\nAsks for regulatory input: Work with the team to understand how you want to observe quality. Paul mentioned that bigger issues that FDA are thinking about are from the IT perspective (making sure that packages don’t compromise infrastructure). Example of haven running into buffer overflow issues. Typically those concerns are raised by security team colleagues. They are not aware of any independent effort to gauge the quality of an R package. Typically they point people to the R Validation Hub. While it is not doing independent replication of algorithms, it is a reasonable attempt in the right direction. Typically all pieces of software give you the “as-is” message and no implied guarantee of quality\nAsks for industry input: Contribute by direct support, or by intermittent feedback as they prepare deliverables\nHigh level of planned deliverables: List of quality criteria, mockup of the communication portal, and an example of a package server modelling a real-world workflow\nVisit the repository to get involved https://github.com/pharmaR/regulatory-r-repo-wg\nBen asked about ways to consolidation various validation efforts heard from other sponsors. What existing tools are being implemented in this space?\nDoug shared an article from the ASA Biopharmaceutical Report regarding the risk assessment of R packages: https://www.pharmar.org/blog/2022/12/05/2022-12-05-asa-biopharmaceutical-report-fall-2022/" + "text": "View Attendee List\n\n\n\n\n\n\nDadong Zhang (Illumina)\nEric Nantz (Eli Lilly)\nEva Li\nGregory Chen (MSD)\nHyeSoo Cho (FDA)\nJizu Zhi (FDA)\nJoel Laxamana (Roche/Genentech)\nJoseph Rickert (R Consortium)\nKaushal Shah (ASU)\nNan Xiao (Merck)\nNing Leng (Roche/Genentech)\nPaul Schuette (FDA)\nRenping Zhang (Johnson & Johnson)\nRobert Devine (Johnson & Johnson)\nSaghir Bashir (Argenx)\nSam Parmar (Pfizer)\nYoun Kyeong Chang (FDA)\nThe meeting was recorded and the video is available." }, { - "objectID": "minutes/2021-09-03/index.html", - "href": "minutes/2021-09-03/index.html", - "title": "Minutes 2021-09-03", - "section": "", - "text": "View Attendee List\n\n\n\n\n\n\n“Christopher Kania - Biogen”\n“Doug Kelkhoff - Genentech”\n“Ning Leng - Genentech”\n“Tadeusz Lewandowski - Roche”\n“Eli Miller - Atorus”\n“Eric Nantz - Lilly”\n“Joseph Rickert - R Consortium”\n“Paul Schuette - FDA”\n“Kevin Snyder - FDA”\n“Mike Stackhouse - Atorus”\n“Ben Staub - GSK”\n“Adrian Waddell - Roche”\n“Nan Xiao - Merck”\n“Jiang Xu - FDA”\n“Renping Zhang - FDA”\n“Yilong Zhang - Merck”\n“Jizu Zhi - FDA”\n\n\n\n\nJoseph Rickert brought the meeting to order at 9:04 and began the video recording. He mentioned that Eli Miller reported although we do have credentials to use the FDA submissions gateway, these have timed out. Reactivating gateway access requires that I send an email to the FDA help desk. Eli recommends that I wait until we are nearly ready to submit before doing this.\nNext, Ning Leng presented the recently up dated slides describing the R Submissions Pilot. Ning will upload this slides to the repo.\n\nThe slides include the working time line for the series of pilot submissions:\n\nPilot1: common analysis (Q4 2021 - hopefully Oct/early Nov)\nPilot2: advanced analysis (Q2 2022)\nPilot3: alternative formatting for package submission (TBD)\n\nTimeline for near term work: * 9/30/2021 complete the draft code and documents along with the internal review by the execution team * 10/1 - 10/15 2021: review by the WG * Late Oct: actual submission after adjudication\nThe two major asks from the execution team: 1. WG members: provide feedback during the review in Oct 2. FDA: Identify potential reviewers\nNext, there was a discussion about the content of the submission package and terminology. (9:48 in the video). This discussion also contains and explanation of the strategy for encoding the R package as a text file to get it through the gateway and how we will handle package dependencies.\nIn our documentation and communication we must be careful to distinguish between the Submission package for the pilot and the R Package containing R code that will be a part of the Submission package. Ning and the team will come up with names for both of these maybe: Pilot1 Submission for the Pilot1 Submission Package. The format for the Submission package will match the folder structure for the submission portal.\nJoe then noted that we now have two R Consortium GitHub repositories associated with the working group. 1. https://github.com/RConsortium/submissions-wg is the primary repository for the working group. The Kanban board project on this repo is what we use to manage the submissions project. 2. The repo https://github.com/RConsortium/submissions-pilot1 is the code development repo for the Pilot1 submission.\nNext, Adrian walked through the status of the tasks on the Kanban Board. (20:19 on the video).\nJoe will write a blog post to describing what the submission team is doing with the intention of getting more pharma companies before the submission. Mike Stackhouse will help with getting it through the PHUSE marketing channels.\nThere was a discussion (43:30) about finding an FDA reviewer for the pilot. Paul Schuette took the action item to find someone who will probably be a statistician but not a formally designated FDA reviewer. It was suggested that the criteria for reviewing the pilot submission and the criteria for the success of the project be included in the cover letter.\nJoe asked what would be required to communicate the success of the pilot. Paul stated that formal approval from the FDA would be required for a press release and that the project should be included as part of the FDA’s Technology Modernization Action Plan (T-MAP) and the Data Modernization Action Plan (D-MAP). It would be best to investigate this after we have the proof of concept of the Pilot1.\nIn response to the question if eventually we would want to have the pilot reviewed by a formal FDA reviewer, Paul noted that they have several R competent FDA reviewers especially among the new graduates. However, if a reviewer need help they would most likely reach out to the Paul’s group.\nWhen asked whether would expect reviewers to compare SAS and R results, Paul suggested that we should focus on a limited definition of validation for our first submission.\nWhen asked whether we should have a future goal of having FDA reviewers to take the code in the submission package and and do further analyses, Paul stated that they can do that now. More interesting would be to have the submission package include a Shiny application for interactive data visualization.\nAt the top of the hour Joe asked whether anyone on the call was involved with preparing a presentation about the Submissions project for the upcoming R / Pharma conference. Paul responded that he may be. The FDA is still working out the details of a keynote talk in which Paul will participate. The group extended an offer to help provide material.\nThe group agreed to extend the meeting beyond the hour to review Ning’s proposal for language to be added to section 4.1.2.10 of the Study Data Technical Performance Guide. (1:03 on video) Ning suggested adding:\n\nSubmission of programs with their native file extensions are acceptable, as long as binary file formats and pre-compilde code are not delivered.\n\nPaul stated that .bat files need to be excluded. This launched a discussion of how to generalize this. Paul suggested executable but Doug noted that .bat files are executable on Windows but not on other operating systems. Doug took the action to consider how to describe the issue in a more general fashion. Paul expressed the essential idea as “We can open it, we can look at it, but we don’t want it to run.”\nIn the final minutes, Adrian asked about not having to submit .txt files. Paul suggested that this would require changes within the Agency, and would probably require getting the suggested changes to 4.1.2.10 passed.\nThe next meeting is scheduled for Friday, October 1, 2020. At that meeting we will decide whether we need a special session to provide material for Paul’s presentation.\nThe zoom video recording is available. Passcode: #Sk!6tXL" + "objectID": "minutes/2024-02-02/index.html#pilot-3", + "href": "minutes/2024-02-02/index.html#pilot-3", + "title": "Minutes 2024-02-02", + "section": "Pilot 3", + "text": "Pilot 3\nHye Soo Cho presented a summary of the findings of the from the FDA review\n\nDifferent versions of R and RStudio\n\nThere were issues switching between R versions\nThe FDA would like the wg to explore the impact of different versions of R,RStudio and RTools\nAlso Linux vs. Windows\n\nDifferences between generated Pilot 2 ADaM and CDISC data sets\n\nattributes\ntypes (e.g. integer vs. double)\nNA vs. NULL\n\nPackage and file names\n\nIncorrect package name (pilot3utils)\nFile name change (Pilot 3.xlsx to adam-pilot-3.xlsx)\n\nFile path\n\nThe location of a director was specified using relative file path\nRecommendation: use full path name\n\nDifferent primary output in Pilot 1 and Pilot 3\n\nThere are discrepancies between Pilot 3 ADaM and CDISC datasets\nDiscrepancies are noted in QC findings in ADRG\n\n\nThere was considerable discussion about the challenges of dealing with different R versions and establishing a Windows test environment to test a submission before transmitting it to the FDA.\n\nThe idea of setting up a gold standard windows test environment was considered but reject as beginning impractical. The actual FDA environment changes frequently because of hot fixes addressing security concerns.\nIt appears that the most practical path forward as to what preemptive measures sponsors can take to match submission environments with the FDA test environment is to work with the FDA to lock down the environment as best as can be done just prior to submission.\nAn interesting note: Paul mentioned that the FDA no longer pushes the idea of last observation carried forward for imputations. They favor exploring multiple imputation methods.\n\nActions:\n\nThe FDA will consider the implications of what was discussed today and decide if we are ready to resubmit Pilot 3 by the next meeting in March. The submission will use the .zip approach.\nJoel agreed to speak with Eric about establishing an automated way to set up a container running a “vanilla” Windows test environment. Note: in a series of private email conversations after the meeting Robert Devine volunteered his expertise to work with Eric and Joel to set up the windows environment." }, { - "objectID": "minutes/2024-04-05/Index.html", - "href": "minutes/2024-04-05/Index.html", - "title": "Minutes 2024-04-05", - "section": "", - "text": "View Attendee List\n\n\n\n\n\n\nBen Straub (GSK)\nEric Nantz (Eli Lilly)\nGregory Chen (MSD)\nHeidi Curinckx (Johnson & Johnson)\nHyeSoo Cho (FDA)\nJizu Zhi (FDA)\nJoseph Rickert (R Consortium)\nNan Xiao (Merck)\nNing Leng (Roche/Genentech)\nPaul Schuette (FDA)\nRobert Devine (Johnson & Johnson)\nSaghir Bashir (Argenx)\nSam Parmar (Pfizer)\nKangjie Zhang (Bayer)\nYoun Kyeon Chang (FDA)\nThe meeting was recorded and the video is available." + "objectID": "minutes/2024-02-02/index.html#pilot-4", + "href": "minutes/2024-02-02/index.html#pilot-4", + "title": "Minutes 2024-02-02", + "section": "Pilot 4", + "text": "Pilot 4\nEric provided a brief update on Pilot 4.\n\nHe will convene the Pilot 4 team to test the Webassembly submission,\nThe submission should be ready by mid March.\nWe will decide on an actual submission date in March.\nEric will invite the Appsilon engineers who have be providing assistance on the project to one of our meetings as we get closer to the submission.\nThe container version of the Pilot 4 submission will coordinate with the FDA to make arrangements for working with containers." }, { - "objectID": "minutes/2024-04-05/Index.html#pilot-3-update", - "href": "minutes/2024-04-05/Index.html#pilot-3-update", - "title": "Minutes 2024-04-05", - "section": "Pilot 3 Update", - "text": "Pilot 3 Update\nBen Staub provided an update on Pilot 3\n\nThe Pilot 3 team is ready to make the resubmission.\nThe team will make the submission on Friday, April 12.\nNing will alert Bev at Roche who tests the gateway connection and makes the actual submission.\nIf all goes well, we expect the FDA could produce an evaluation report in late June or early July." + "objectID": "minutes/2024-02-02/index.html#presentation-to-swiss-medic", + "href": "minutes/2024-02-02/index.html#presentation-to-swiss-medic", + "title": "Minutes 2024-02-02", + "section": "Presentation to Swiss Medic", + "text": "Presentation to Swiss Medic\nOn January 30, Gregory Chen presented the activities of our working group in person to an audience 15 people at the swissmedic regulatory agency and 50 people online. Gregory’s slides are in the github repository. He summarized the discussion that took place after his presentation.\n\nThe swissmedic audience was very interested in the use of Shiny for the Pilot 2 submission and would like to work with the R Consortium to explore the possibility of doing something similar at swissmedic. They discussed two possible ways to proceed:\n\nA Pilot 2 like project\nHaving sponsors set up a cloud environment\n\nThe swissmedic audience said that they would prefer an industry collaborative effort rather than a vendor specific solution.\nThe were interested in learning about the resources the FDA allocated to the Pilot 2 and * asked about creating Shiny applications for market authorization.\nThe WG was excited about the possibility of collaborating with swissmedic\nHowever, after some discussion it was decided that this opportunity should be pursued by a new working group devoted to swissmedic.\nWe should also find out if swissmedic has discussed these ideas with the EMA.\n\nAction:\n\nJBR will work figure out how best to recruit members for a new working group focused on swissmedic.\nThis should include a call to the industry to identify people with European connections who could lead this effort.\n\nThe next meeting of the working group will be at 9AM PST on Friday, March 1, 2024,\n\nAbstract for Gregory’s Presentation\nName of presenter: Gregory Chen\nAffiliation: MSD, Switzerland; R Submission Working group (R Consortium)\nBrief introduction of the working group:\nThe R submission working group is a cross-industry working group in pharma, focusing on improving practices of R-based clinical trial regulatory submissions. Our mission is to make R-based clinical trial regulatory submissions easier today and tomorrow by\n\nshowing open examples of using current submission portals,\ncollecting feedback and influencing future industry and agency decisions on system/process setup\n\nTitle: R and Shiny in regulatory submission\nAbstract:\nIn recent years, statisticians and analysts from both industry and regulatory agencies have increased adoption of open-source software such as R. Compared to other statistical programming languages, R brought great benefit from its vibrant open-source community, providing a wealth of cutting-edge statistical tools and adaptability to the latest data science trends. Particularly, R shiny provided great flexibility and interactivity to increase data scientists productivity and make it easier to extract insights or review through massive statistical outputs. To test the concept that R language and shiny app can be bundled into a submission package and transferred successfully to FDA reviewers, the R Submission Working group (R Consortium) successfully completed two pilot submissions to FDA fully in R, and received CDER response letters (pilot 1, pilot 2). To our knowledge, these are the first publicly available submission packages that include components of open-source languages. In this talk, we will introduce R consortium, particularly its Submission Working group, and the completed pilot 1 and 2." }, { - "objectID": "minutes/2024-04-05/Index.html#pilot-4", - "href": "minutes/2024-04-05/Index.html#pilot-4", - "title": "Minutes 2024-04-05", - "section": "Pilot 4", - "text": "Pilot 4\nEric Nantz reported on the Plot 4 effort. (9:11 into the video)\n\nWASAM Version\nEric asked for guidance on the placement of the zip file containing the application source files in the eCTD bundle. The WG decided that the placement indicated in the figure below looks fine.\n The ADRG will provide instructions for running the application. The workflow will be something like:\n\nUnzip the file\nExecute the functions provided to compile the WASM application\nExecute the functions provided to run the application. Two versions of execution functions will be provided:\n\n\nFunctions to execute with WASM\nFunctions to run a normal Shiny app as in Pilot 2\n\nDecisions were made:\n\nto continue zip files for M5, and not M#, even though this may throw a low level error.\nto keep the datasets in a sub directory of the directory containing the WASM code without having to copy them into a another location before building the app.\n\nA question was asked about what persists on the workstation when the browser is closed. The answer was: not much persists on the machine. It may be the case that some information is cached but nothing is written to the disk.\nA question was asked about having a short cut to launch the application. The answer is that in the current state of WebAssembly it is necessary to start a new R session (or other process) that can serve static files.\nAlso note the the process that spins up WebAssebly installs the required R packages. Unfortunately, with the current state of the technology there is no way to snapshot the versions of the packages.\n\n\nContainer Version\n\nA major development at the FDA is that FDA IT rejected the request to use Podman, but recommended that we use Docker.\nEric will include instructions in the ADRG to setup and run Docker containers." + "objectID": "minutes/2022-10-07/index.html", + "href": "minutes/2022-10-07/index.html", + "title": "Minutes 2022-10-07", + "section": "", + "text": "View Attendee List\n\n\n\n\n\n\nEllis Hughes (GSK)\nEric Nantz (Eli Lilly)\nHonghong Zhou (Moderna)\nJizu Zhi (FDA)\nJoseph Rickert (R Consortium)\nLei Zhao (Roche/Genentech)\nMiriam Fossati (Merck)\nNan Xiao (Merck)\nNing Leng (Roche/Genentech)\nPhil Bowsher (Posit)\nQin Li\nRenping Zhang (Johnson & Johnson)\nRobert Devine (Johnson & Johnson)\nRyan Johnson (Posit)\nSaghir Bashir (Argenx)\nSam Parmar (Pfizer)\nSean Healey (Pfizer)\nTadeusz Lewandowski (Roche/Genentech)\nThomas Neitmann (Roche/Genentech)\nYilong Zhang (Meta)\nThe meeting was recorded and the video is available." }, { - "objectID": "minutes/2024-04-05/Index.html#communication-and-documentation", - "href": "minutes/2024-04-05/Index.html#communication-and-documentation", - "title": "Minutes 2024-04-05", - "section": "Communication and Documentation", - "text": "Communication and Documentation\n\nJoe pointed out the infrastructure developed by the Submissions working group is significant and complex and that it is difficult to explain. He asked if we should undertake an effort to expand the website to include materials to explain the processes and technology to newcomers and document the history of what has been done.\nNing suggested that we follow the lead of the R Valid Hub and look for a communications manager or assemble a small team.\nEric noted that we have been focused on the submission itself and do not want to take on the challenge of how companies might establish their internal environments. All agreed with this.\nJoe pointed out that the fact that Ning was chatting with Doug Kelkhoff is a good sign that there seems to be sufficient communication among the working groups to keep the working groups focused and avoid duplication.\nSam suggested putting a start here page and time line on the webpage. For example, see the NEST Timeline.\nEric noted that there might be a quarto extension to do a time line.\nA suggestion was made to compile all of our presentation.\nThe WG will open an issue on the submission-wg repository to collect ideas\nhe R for Clinical Study Reports and Submission website might serve as a model.\n\n\nActions\nJoe will:\n\ncompile suggestions for improving the website\nSee what help the RC marketing team can provide\nstart looking for a communications manager" + "objectID": "minutes/2022-10-07/index.html#da-japan-talk", + "href": "minutes/2022-10-07/index.html#da-japan-talk", + "title": "Minutes 2022-10-07", + "section": "DA Japan Talk", + "text": "DA Japan Talk\n(31:30 min into video) Tadeusz presented a Shiny application that he developed for a presentation he is going to make at the DIA Japan conference on October 9, 2022. The intention of the presentation is to gauge the interest of the Japanese authorities. The session in which Tadeusz will present is called LS09 Innovative and Dynamic Statistical Analytics for Regulatory Submissions" }, { - "objectID": "minutes/2024-04-05/Index.html#conference-presentations", - "href": "minutes/2024-04-05/Index.html#conference-presentations", - "title": "Minutes 2024-04-05", - "section": "Conference Presentations", - "text": "Conference Presentations\n\npharmaSUG - May 19 to 24\n\nAppsilon is planing a presentation on Pilot 4 work: SS-376 : Experimenting with Containers and webR for Submissions to FDA in the Pilot 4, André Veríssimo and Ismael Rodriguez Appsilon of Appsilon.\nSS-344 : Piloting into the Future: Publicly available R-based Submissions to the FDA by Benjamin Straub, GlaxoSmithKline\n\nUseR! 2024\n\nNing has submitted an abstract about Submissions WG work\n\nNing and Eric will be presenting at the DIA webinar\n\n\nActions\n\nJoe will ask RC marketing to prepare an RC slide for Sam and Appsilon to use in their presentations\nNing will provide the details on the DIA webinar so we can promote it." + "objectID": "minutes/2022-10-07/index.html#subgroups", + "href": "minutes/2022-10-07/index.html#subgroups", + "title": "Minutes 2022-10-07", + "section": "Subgroups", + "text": "Subgroups\nThe working group discussed writing writing some material for the GitHub repository explaining the purpose of the various subgroups, listing the members, and explaining how newcomers can get involved.\nAction Item Joe and Eric will meet after the Pilot 2 submission to discuss documenting the subgroups." }, { - "objectID": "minutes/2024-04-05/Index.html#recommended-r-versions", - "href": "minutes/2024-04-05/Index.html#recommended-r-versions", - "title": "Minutes 2024-04-05", - "section": "Recommended R Versions", - "text": "Recommended R Versions\nIt turns out that making a recommendation for the version of R for companies to used in their submissions that would best harmonize with the versions that are likely to be in use at the FDA is much harder than we anticipated. Even our phrase for identifying our recommendation “Last patch version of the previous subversion” is not without ambiguity.\n\nIt is likely that each company will have its own approach to managing versions for submissions\nOur new goal is to see if we can make an R Consortium recommendation that has sufficient industry support.\nThe FDA would like to avoid the extremes:\n\nSubmissions using very old R versions\nSubmissions using the latest R development version\n\nThe FDA would also like to have submissions that are likely to still be available over a six year horizon. (FDA retention rules are six years.)\nNing proposed a series of posts from different companies on how they deal with versioning.\nAfter we have published a few posts we will survey the industry.\n\n\nAction\n\nNing will draft a post on the Roche approach\nJoe will have R Consortium Marketing produce the post" + "objectID": "minutes/2022-10-07/index.html#containers", + "href": "minutes/2022-10-07/index.html#containers", + "title": "Minutes 2022-10-07", + "section": "Containers", + "text": "Containers\nThe working group agreed that the planned project to submit a containerized version of the Pilot 2 submission will require a significant amount of new work and pose several challenges. It should therefore be new, independent pilot submission, perhaps Pilot 4-Containers." }, { - "objectID": "minutes/2024-04-05/Index.html#next-meeting", - "href": "minutes/2024-04-05/Index.html#next-meeting", - "title": "Minutes 2024-04-05", - "section": "Next meeting", - "text": "Next meeting\nThe next meeting of he working group will be on Friday, May 3, 2024 at 9AM Pacific Time." + "objectID": "minutes/2022-08-05/index.html", + "href": "minutes/2022-08-05/index.html", + "title": "Minutes 2022-08-05", + "section": "", + "text": "View Attendee List\n\n\n\n\n\n\nDadong Zhang (Illumina)\nEric Nantz (Eli Lilly)\nGabriel Becker (Roche/Genentech)\nHenry Wang (Roche/Genentech)\nJoseph Rickert (R Consortium)\nNing Leng (Roche/Genentech)\nPaul Schuette (FDA)\nRenping Zhang (Johnson & Johnson)\nRobert Devine (Johnson & Johnson)\nSaghir Bashir (Argenx)\nSean Healey (Pfizer)\nXin Qiu (Johnson & Johnson)\nYilong Zhang (Meta)\n\n\n\n\nThe meeting was recorded and the video with passcode: wW@9+Lbx\nNL asked if the R Consortium could establish an RStudio connect server to host the Pilot 2 Shiny submission App which is currently deployed on a Genentech server (https://genentech.shinyapps.io/FDA-app/).\nAction Item: JR will contact RStudio to see what it would take to set up the server.\nNL and EN reported that the Pilot 2 team is in the final stages of preparation. The team recently set up Pilot 2 on the golem framework. teal has been fully incorporated, and the team is in the finals stages of completing the documentation preparing the submission. NL estimates that a submission in mid August is possible.\nAction Item: JR will connect with James Black to determine how Roche wants to announce the open sourcing of teal.\nJR asked for updates from the efforts to make pilot submissions to the authorities in Japan and China. Based on conversations with her Roche colleagues, NL reported that there have be no new developments. The Japanese agency doubts that they have the resources to evaluate a pilot submission. The Chinese authority still appears to be interested in an industry collaboration. Roche China is attempting to form a working group, Ning offered to put anyone interested in touch with here Chinese colleague leading this effort.\nJR asked: under the assumption that Pilot 2 goes really well, does the WG have any concrete suggestions for advancing the use of Shiny in submissions. EN noted that just getting Shiny in the process is a big step.\nThere was some discussion about the target audience for the Pilot 2 submission, and how the Shiny app might appeal to a larger FDA audience than the statisticians who would review a submission.\nThere was a questions about whether FDA reviewers would want to reproduce the Shiny app interactivity. PS noted that FDA reviewers are not Shiny app developers and it is unlikely that the FDA would want to go down that path. GB asked for clarity on the term “independent reproducibility”. PS noted that running the sponsors code in the same environment used by the sponsor is not considered to be independent verification.\nNL asked about specific use cases that may be of interest to the FDA. PS noted that standing up a Shiny app in a real product submission workflow would be more complicated than one might expect because it would have to be integrated into an FDA contractor’s workflow. Using the current infrastructure, it is best to think of a Shiny app being run on an individual’s computer.\nThe discussion turned to the use of containers for submissions. JR asked PS whether about the FDA landscape for containers. PS replied that currently podman has been approved by NCTR, and that if we would like to use that he would have to get approval for CDAR use. Docker is not viable in the short term because of the subscription model, which would require coordination among multiple offices.\nER noted that in addition to podman and Docker he had identified singularity as a possible candidate container technology, but that this product is not as accessible to developers. In his organization, singularity requires an IT administrator to setup. PS noted that if this working group would identify a preferred container technology, he could begin promoting our choice within the FDA.\nYZ asked if we should think about writing up the Pilot 1 and Pilot 2 experience for a journal publication, perhaps a two page letter. The group liked the idea and suggested R journal, ASA Journals, Significance, Chance, DIA Journals, JSS, JAMA and a clinical trials journal were suggested as possibilities.\nNL asked about the possibility of presenting to FDA statisticians. PS said that he would have to consult with FDA management.\nPS suggested something like the recent R Adoption Series Webinar which drew 600 people from industry would be viable. He would invite members of the internal FDA Statistics Association to attend. He suggested a discussion / capstone effort: “Working through the R Consortium industry and the FDA have collaborated with industry in an appropriate way and gone through a step by step process that has involved the FDA at each step.\nAction Item JR and NL to arrange this webinar.\nNext the grouped discussed whether it would be worthwhile to do an additional pilot that would include data generation. The idea would be to start with CDISC SDTM data and derive the data for analysis such as change from baseline etc. PS said that this would be interesting, but that most reviewers start with the analysis data steps. More motivated reviewers will trace key variables to show that they can be independently reproduced. No decision was reached on this matter.\nPS suggested that the WG consider participating in the CDISC TFL Designer Virtual Workshop which will be held on 13 September 2022, 11am - 2pm Eastern Time. Register Here.\nAction Item The group will try to find someone from CDISC who may involved and also search for someone from the working group who might want to attend. JR will write to James Black to see if he has any knowledge of the event.\nThe next meeting of the working group will be at 9AM Pacific Time on Friday, September 2, 2022." }, { - "objectID": "minutes_prep.html", - "href": "minutes_prep.html", - "title": "Minutes Document Writer", + "objectID": "minutes/2023-03-03/index.html", + "href": "minutes/2023-03-03/index.html", + "title": "Minutes 2023-03-03", "section": "", - "text": "This interactive page creates a template Quarto document text for capturing meeting minutes associated with the Submissions working group.\n\n\nUse the date input below to choose the date of the meeting. Click the calendar icon in the widget to launch the UI.\n\nviewof meeting_date = Inputs.date({\n label: \"Meeting Date\",\n value: \"2023-02-01\"\n})\n\n\n\n\n\n\n\nmeeting_year = (meeting_date.getFullYear()).toString()\nmeeting_month = (meeting_date.getMonth() + 1).toString().padStart(2, \"0\")\nmeeting_day = (meeting_date.getDate() + 1).toString().padStart(2, \"0\")\n\nmeeting_array = [meeting_year, meeting_month, meeting_day]\nmeeting_print = meeting_array.join(\"-\")\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nUse the personnel table below to select the attendees present at the meeting by checking the box that appears once you hover your cursor above a name. The table is ordered alphabetically by first name as default, but you can sort by a different column by clicking the column name.\n\n\n\n\n\n\nWarning\n\n\n\nIf an attendee is not listed in this table, please add their name, affiliation, and affiliation URL to the wg_attendees.xlsx spreadsheet located in the data subdirectory of this repository. After your edits to the spreadsheet are completed, re-build the Quarto site.\n\n\n\ndata2 = transpose(people_data)\n\n\n\n\n\n\n\nviewof people_selection = Inputs.table(data2, {\n sort: \"name\",\n multiple: true,\n rows: 40,\n required: false\n})" + "text": "View Attendee List\n\n\n\n\n\n\nBen Straub (GSK)\nEric Nantz (Eli Lilly)\nHyeSoo Cho (FDA)\nJoel Laxamana (Roche/Genentech)\nJoseph Rickert (R Consortium)\nKui Schen (Bayer)\nLei Zhao (Roche/Genentech)\nNan Xiao (Merck)\nPaul Schuette (FDA)\nRenping Zhang (Johnson & Johnson)\nRobert Devine (Johnson & Johnson)\nSaghir Bashir (Argenx)\nSam Parmar (Pfizer)\nSean Healey (Pfizer)\n\n\n\n\nThe meeting was recorded and the video is available.\nDue to a problem with zoom permissions, the meeting started 15 minutes late. Apologize to everyone who was inconvenienced.\n(At 1:37 into the video) HyeSoo Cho begins sharing here screen and providing her comments on the recent Pilot 2 submission.\nA bug in the submission code caused population subsetting in the Kaplan Meier Curve to propagate silently throughout the shiny app. During the course of the meeting Eric Nantz was able to identify the problem as a incorrectly set option and correct it.\nJBR noted that turning off subgrouping for everything but the KM plot was a special requirement for the pilot submission and asked if under normal operation whether the FDA reviewers would like the shiny app to display this default behavior. (The alternative would be for app users to remember to turn on the same subgrouping for every plot or table in order to make comparisons.) HeySoo and Paul Schuette provided an explanation of the FDA’s need to be very careful of subgroup analysis.\nPaul emphasized that it is very important to distinguish between “exploratory analysis” and analysis for “inferential analysis”. Subgrouping that causes p-values to change cross the line between the two types of analyses. The FDA is very concerned that the misuse of subgrouping could lead people to improperly argue for evidence of efficacy based on restricted subpopulations. When asked if he was advising that submissions should not contain interactive capabilities Paul replied “No”. He elaborated that nothing interactive should produce a p-value.\n(10:48 into the video) Ning Leng asked if subpopulation analyses associated with predefined endpoints would be permissible as this would distinguish between inferential and exploratory analyses. Paul replied this is correct. He noted that prespecified subgroup analyses will often product confidence intervals but not p-values.\n(At 19:56) Eric announced the resolution to the parameter problem and the group agreed that we have a path forward for the current Pilot 2 submission. Eric also suggested that the interactivity may be the biggest topic for the group to discuss. Paul asked to defer the discussion of this bigger issue and suggested that the working group look to the ASA statement on p-values for guidance.\n(18:36) The FDA does not want to be seen as endorsing the practice of rescuing a “failed” clinical trial by torturing the data. He noted that even now there is a problem with JMP and other tools that that are interactive but do not produce an open and fully transparent analysis true.\nInteractive tool must be open, transparent, reproducible, and consistent with good statistical practices. Paul suggested that an interactive tool that produces interactive tools on demand may not be consistent with the ASA statement on p-values.\nIn response to a question, Paul affirmed that the ASA statement in p-values is a good foundation for understanding FDA practices.\n(22:57) Begins a discussion on shinymeta and reproducibility. It as also noted that the teal project is also addressing this reproducibility issue.\n(27:43) HeySoo resumes her comments on the Pilot 2 submission by commenting on the warning and error messages generated by the submission code, and points out that referencing a repository other than CRAN is problematic. Paul noted that FDA IT security is insisting on strong security checks, but that a case can be made that CRAN provides sufficient checks. He said that his group at the FDA is floating the notion of “curated” packages.\nHeySoo suggested that providing a README file that discusses all the potential error and warning messages and what needs to be done to run the app properly. Paul noted that some of this information should be included in the app to make it as stand alone as possible.\nThe working group agreed that the next step should be to produce an updated Pilot 2 submission package and resubmit it through the gateway. This will make it for the FDA to produce a written response. We will proceed with Pilot 2 take 2.\nEric will deploy will a new version on our internal host so that everyone can review it before the second submission.\nWhen asked if the FDA security work Paul mentioned would lead to a guidance document, Paul replied that it may and noted that there is an internal FDA working group addressing the problem, and that currently Python appears to be a bigger security problem than R.\n(44:26) Paul informed the group that the FDA is being approached by multiple groups, including PhUSE and Transcelerate, about using R and validation issues. The FDA would coordinate the activities of these groups to prevent duplication of effort and decide who is going to do what. He also suggested that we should broaden our base within the FDA and seek to get John Scott and CBER involved.\nAction JBR will invite someone from the R Validation Working Group to attend our next meeting and meet with Paul to identify a representative from PhUSE to invite.\nThe next meeting of the Submissions Working Group will be on Friday, April 7, 2023 at 9AM PST." }, { - "objectID": "minutes_prep.html#date-selection", - "href": "minutes_prep.html#date-selection", - "title": "Minutes Document Writer", + "objectID": "minutes/2023-04-07/index.html", + "href": "minutes/2023-04-07/index.html", + "title": "Minutes 2023-04-07", "section": "", - "text": "Use the date input below to choose the date of the meeting. Click the calendar icon in the widget to launch the UI.\n\nviewof meeting_date = Inputs.date({\n label: \"Meeting Date\",\n value: \"2023-02-01\"\n})\n\n\n\n\n\n\n\nmeeting_year = (meeting_date.getFullYear()).toString()\nmeeting_month = (meeting_date.getMonth() + 1).toString().padStart(2, \"0\")\nmeeting_day = (meeting_date.getDate() + 1).toString().padStart(2, \"0\")\n\nmeeting_array = [meeting_year, meeting_month, meeting_day]\nmeeting_print = meeting_array.join(\"-\")" + "text": "View Attendee List\n\n\n\n\n\n\nAmanda Martin\nAndrew Borgman (Bristol Myers Squibb)\nBen Straub (GSK)\nHeidi Curinckx (Johnson & Johnson)\nHyeSoo Cho (FDA)\nJoel Laxamana (Roche/Genentech)\nKui Schen (Bayer)\nLei Zhao (Roche/Genentech)\nNan Xiao (Merck)\nNate Mockler (Biogen)\nNing Leng (Roche/Genentech)\nPaul Schuette (FDA)\nRobert Devine (Johnson & Johnson)\nSaghir Bashir (Argenx)\nSam Parmar (Pfizer)\nSean Healey (Pfizer)" }, { - "objectID": "minutes_prep.html#attendee-selection", - "href": "minutes_prep.html#attendee-selection", - "title": "Minutes Document Writer", - "section": "", - "text": "Use the personnel table below to select the attendees present at the meeting by checking the box that appears once you hover your cursor above a name. The table is ordered alphabetically by first name as default, but you can sort by a different column by clicking the column name.\n\n\n\n\n\n\nWarning\n\n\n\nIf an attendee is not listed in this table, please add their name, affiliation, and affiliation URL to the wg_attendees.xlsx spreadsheet located in the data subdirectory of this repository. After your edits to the spreadsheet are completed, re-build the Quarto site.\n\n\n\ndata2 = transpose(people_data)\n\n\n\n\n\n\n\nviewof people_selection = Inputs.table(data2, {\n sort: \"name\",\n multiple: true,\n rows: 40,\n required: false\n})" + "objectID": "minutes/2023-04-07/index.html#pilot-2-update", + "href": "minutes/2023-04-07/index.html#pilot-2-update", + "title": "Minutes 2023-04-07", + "section": "Pilot 2 Update", + "text": "Pilot 2 Update\nEric Nantz provided the following update:\n\nHe has solved the filtering bug and has verified the app is working correctly with additional testing.\nHe is incorporating ADRG material into the intro guide\nPaul suggested adding a list of steps and has offered to discuss details offline.\nNing will work with Bev to make sure we are good to go with the gateway\nThe Pilot 2 re submission is set for 9AM on Friday, April 21, 2023. Joe will schedule the meeting (Bev, Eric, Hye Soo, Paul, Ning)" }, { - "objectID": "minutes_prep.html#setup", - "href": "minutes_prep.html#setup", - "title": "Minutes Document Writer", - "section": "Setup", - "text": "Setup\nIn your local copy of this repository, create a sub-directory within the minutes directory to hold files associated with this meeting’s minutes. Based on your selection above, create the following directory:\n\nmeeting_print\n\n\n\n\n\n\nCopy the text in the output below into a new Quarto document named index.qmd.\n\nsilly = html`${Array.from(new Set(people_selection.map(c => c.name2)))\n.sort()\n.map(c => `- ${c}`)\n.join(\"\\n\")}`\n\nsilly2 = html`<pre>---\ntitle: \"Minutes ${meeting_print}\"\ndate: ${meeting_print}\n---\n\n::: {.callout-tip collapse=\"true\"}\n## View Attendee List\n\n${silly}:::\n\n## Add Minutes Here\n\n</pre>`\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nsilly2" + "objectID": "minutes/2023-04-07/index.html#pilot-3-progress-update", + "href": "minutes/2023-04-07/index.html#pilot-3-progress-update", + "title": "Minutes 2023-04-07", + "section": "Pilot 3 Progress Update", + "text": "Pilot 3 Progress Update\nJoel Laxamana provided the following update.\n\nAll 5 ADaMs now generated and in review.\nPer development steps, we have noted discrepancies or findings when comparing our Pilot 3 ADaMs with the original Pilot 1 ADaMs. You may see these noted in our Wiki here : https://github.com/RConsortium/submissions-pilot3-adam/wiki/QC-Findings .\nMinor updates are being made to clean up code, updating our variable labels appropriately and updating the ADaM specifications (define) to meet CDISC guidance as we go through our routine P21 checks.\nWe are also currently developing our ADRG based off of the Pilot 3 specifications we are reading into P21. We plan to use the P21 ADRG as a base, then we will add in information similar to that of Pilot 1 for complete instructions prior to submission.\nAs we finalize both the define and the ADaMs, we are also developing a batch run code to run all of our ADaM and TLF scripts, with that we are looking into implementing dependency recognition using a package called {targets} (e.g. before ADAE is run, checks latest ADSL code has been run first).\n\nAdditionally, we are rerunning all TFL scripts from Pilot 1 and re-sourcing the Pilot 3 data.\nOnce the above is finalized, we will do a batch run, check against P21, then bring everything over into our eSubmission repo. We have made contact with Roche’s Regulatory function who will help support the preparation of our eSubmission in eCTD structure.\n\n\nCurrent Project workflow discussion as seen in Pilot 1:\n\nUpon reviewing Pilot1’s work and the R4CSR guidance they have followed, we see the current flow suggests the use of 2 repos : 1)Project repo & 2)Submission repo\nIn the project repo, this includes the project analysis R scripts (ADaMs and TFLs) and R utility functions within the same package.\n14.2.2 programs\nFolder path: ectddemo/m5/datasets/ectddemo/analysis/adam/programs/.\nr0pkgs.txt: contains all internally developed proprietary R packages. Other .txt files: each contains R code for a specific analysis.\nThey also suggest using .RMD files as the source analysis scripts, which are then converted to .R/.txt for submission.\nThen all .txt are brought over to the Submission repo to deliver to Regulatory for eCTD structure and formal submission to the FDA portal.\n\nIn Pilot 3 our project flow emulates more of the usual project work we would see in our companies.\n\nFor instance, our source code will just use plain .R instead of .RMD as source analysis code. Especially for ADaMs, it make more sense to just start in .R scripts.\nFor the most part Pilot3 will follow the same submission process as Pilot1, but the minor difference will just be our project flow. I.E., Pilot 3 will separate the Utility functions from the Project analysis scripts into different repos. It makes more sense to treat the study specific utility functions as separate package, similar to how we call on other R packages from CRAN or other git repositories, where then the project analysis repo scripts will call on the aforementioned study specific utility functions package. This is still in line with the R4CSR guidance in section 14.3\n\nFollowing this approach, makes it clear from a study perspective where the utility functions are being called from, where the project analysis scripts are stored and developed and where the submission will be. For illustration purposes we have this graphic (Thanks, Thomas Neitman!):\n\n\n\nProposed Pilot 3 Repo Setup\n\n\n\nOverall, to our Health Agencies, the single source of truth will of course come from our ‘Submission’ repo, where they may not need all of the details of the study project flow steps. We just wanted to be able to discern that R packages should be kept in their own packages and project analysis work should not be stored as a package.\n\n\nPOST Meeting notes/actions from R Consortium Submissions WG (07Apr2023) :\n\nPer Paul Schutter, Pilot 3 needs a link to the ‘FREE’ P21 version that the Pilot 3 team should be using. Paul to share link with Joel. We should also include SDTM in the P21 run, but just mention in the ADRG that we will not be updating or fixing the SDTMs due to any P21 issues to follow the same approach as Pilot 1. Though Pilot 3 is mainly focused on ADaMs, we do plan on fixing the P21 issues the best we can and noting discrepancies compared to the CDISCPILOT data.\nNeed new repo from submission_wg to store the utility functions into. Joe R, could you help us with this?\nFor the study project repo set-up, there are example template repos that can be followed. Pilot 3 team to look into this.\nTargeting mid-June 2023 to wrap-up submission.\nLink to all Pilot 3 members, for Eric to include in Submission WG webpage : https://rconsortium.github.io/submissions-pilot3-adam/main/" }, { - "objectID": "pilot4.html", - "href": "pilot4.html", - "title": "R Submission Pilot 4", - "section": "", - "text": "Goal: Utilize alternative methods of distributing a self-contained submission bundle of the Pilot 2 Shiny application with container and web-assembly technologies.\nKey evaluation aspects:\n\nFor Submitter\n\nGeneration of a reproducible execution environment containing both the system and R-specific dependencies using Podman as the container runtime.\nGeneration of a web-assembly version of the Pilot 2 Shiny application (with small modifications) that can be executed in an existing R process running a web server using the {httpuv} R package\nPreparation of submission materials with detailed instructions on setting up the execution environments\n\nFor FDA Staff\n\nReproduce the ability to use the Shiny application by building the specific Podman container and viewing the web-assembly version of the application using the Edge internet browser.\n\n\nTimeline: Targeting a first submission in Q2 2024\nData and analysis scope:\n\nA shiny app that replicates most of the functionality from the pilot 2, with small modifications to account for the web-assembly constraints.\nSimulated data from CDISC Pilot (the same data set as in pilot 1)\n\nLinks:\nR Submission Pilot 4 Container Development Repository\nR Submission Pilot 4 Web-Assembly App Repository\nKey team members\nDeveloper team:\n\nEric Nantz (Eli Lilly)\nSam Parmar (Pfizer)\nPedro Silva (Appsilon)\nIsmael Rodgriguez (Appsilon)\nAndre Verissimo (Appsilon)\nRobert Devine (J&J)\nNate Mockler (Biogen)\nAndrew Borgman (Bristol Myers Squibb)\nBen Straub (GSK)\n\nFDA Staff:\n\nPaul Schutte\nHye Soo Cho" + "objectID": "minutes/2023-04-07/index.html#pilot-4", + "href": "minutes/2023-04-07/index.html#pilot-4", + "title": "Minutes 2023-04-07", + "section": "Pilot 4", + "text": "Pilot 4\nEric Nantz gave a brief update:\n\nEric is starting to build a team and already has some volunteers\nThe effort will focus on container technology\nPaul Schuette will reach out within the FDA to find an FDA participant for this group\nPaul noted that anything having to do with servers would necessarily involve the use of contractors and have to have a budget.\nThere may be a way to have the container run on a laptop and thus avoid the complications caused by servers. *Ning Leng asked Paul if there are any other groups within the FDA that might be interested in pilots. Paul replied that the guidance he has received from management is to hold off on this for the time being." }, { - "objectID": "pilot1.html", - "href": "pilot1.html", - "title": "R Submission Pilot 1", - "section": "", - "text": "Goal: Example R based submission contains common analyses, submission through the current FDA e-submission system and process.\nKey evaluation aspects:\n\nFor Submitter\n\nSubmission of proprietary R packages\nPreparation of R-based submission materials\n\nFor FDA Staff\n\nReproduce analysis results by reconstructing submitted proprietary packages / retrieving open source packages\n\n\nData and analysis scope:\n\n4 TLFs\nSimulated data from CDISC Pilot\n\nSuccess Criteria:\n\nSubmitter:\n\nSuccessfully submit via eCTD portal\n\nFDA Reviewer:\n\nReproduce analysis results\n\n\nTimeline: - Submitted 2021 Nov (v0.1.0) - FDA first response 2021 Nov - Resubmission 2022 Feb (v0.1.0)\nLinks:\nR Submission Pilot 1 Development Repo\nR Submission Pilot 1 eCTD Submission Package to FDA\nAdditional Activities - explore pilot submissions to other HAs (Japan, China)\nKey team members:\nDeveloper team:\n- Ning Leng, Heng Wang (Roche)\n- Mike Stakehouse, Eli Miller (Atorus)\n- Yilong Zhang, Peikun Wu (Merck)\nEsub team:\n- Beverly Chin (Roche)\n- Tim Powell (Biogen)\nFDA Staff:\n- Paul Schuette\n- Hye Soo Cho" + "objectID": "minutes/2023-04-07/index.html#asa-webinar", + "href": "minutes/2023-04-07/index.html#asa-webinar", + "title": "Minutes 2023-04-07", + "section": "ASA Webinar", + "text": "ASA Webinar\nJBR Informed the WG that the ASA New Jersey Chapter has contacted him about doing a webinar on the Submissions WG. The email below outlines a list of options.\n\nThe WG was enthusiastic about doing a robust webinar with multiple talks sometime after the Pilot 2 submission in June.\nPaul said that he would like to participate and asked if other ASA members could attend. Paul noted that he has had requests to speak from pharma companies, but it is difficult for FDA speakers to speak to individual companies without committing to speak to all companies.\nThe WG would like to co-brand the event as an R Adoption Series Event\n\n\nMarch 26, 2023 email from Sciling Ruan\nHi Joe,\nIt was very nice to speak to you last week and learned about what you do in the R-Submission working group. As discussed, we are very interested in collaborating with you to bring the topic of R-submission to our webinar. I also include our ASA NJ Chapter President Dirk Moore in the loop. Dirk is a faculty member in Rutgers University, and he will also help organize the webinar.\nI understand that you will need to discuss this collaboration within your working group. I would like to give more information in case it might be helpful.\nThe webinar can have one presentation or multiple presentations with different perspectives. So I would be interested to know the tentative presentation titles and speakers.\nThe webinar can be set in any date and month. We are very flexible. Normally, to accommodate both east coast and west coast audience, we often recommend the time slot of 11:00-12:00 or till 1:00 EDT on a Friday.\nWe might invite another speaker from a pharma company on their experience with R-submission (if we could identify a good speaker). In that case, the webinar will be two hours with a panel discussion. Will this set up OK with you? Once I have some information to work with, we will follow up with a kickoff meeting including all potential speakers to work out the details. The webinar will use the WebEx platform in Rutgers University. It will be a free event to everyone.\nI look forward to hearing from you. If you need more information from me, please let me know.\nBest regards, Shiling Ruan\n\n\nAdditional Conferences\nIn general, the WG is keen about promoting their work after the submission of Pilot 2 and the group discussed possible opportunities for talks alter this year including the R / Pharma conference and possibly and FDA event. The group will discuss this at the next meeting.\nThe next meeting of the WG will be at 9AM Pacific Time on Friday May 5, 2023." }, { - "objectID": "pilot1.html#pilot-1---common-analyses", - "href": "pilot1.html#pilot-1---common-analyses", - "title": "R Submission Pilot 1", + "objectID": "minutes/2021-01-15/index.html", + "href": "minutes/2021-01-15/index.html", + "title": "Minutes 2021-01-15", "section": "", - "text": "Goal: Example R based submission contains common analyses, submission through the current FDA e-submission system and process.\nKey evaluation aspects:\n\nFor Submitter\n\nSubmission of proprietary R packages\nPreparation of R-based submission materials\n\nFor FDA Staff\n\nReproduce analysis results by reconstructing submitted proprietary packages / retrieving open source packages\n\n\nData and analysis scope:\n\n4 TLFs\nSimulated data from CDISC Pilot\n\nSuccess Criteria:\n\nSubmitter:\n\nSuccessfully submit via eCTD portal\n\nFDA Reviewer:\n\nReproduce analysis results\n\n\nTimeline: - Submitted 2021 Nov (v0.1.0) - FDA first response 2021 Nov - Resubmission 2022 Feb (v0.1.0)\nLinks:\nR Submission Pilot 1 Development Repo\nR Submission Pilot 1 eCTD Submission Package to FDA\nAdditional Activities - explore pilot submissions to other HAs (Japan, China)\nKey team members:\nDeveloper team:\n- Ning Leng, Heng Wang (Roche)\n- Mike Stakehouse, Eli Miller (Atorus)\n- Yilong Zhang, Peikun Wu (Merck)\nEsub team:\n- Beverly Chin (Roche)\n- Tim Powell (Biogen)\nFDA Staff:\n- Paul Schuette\n- Hye Soo Cho" + "text": "View Attendee List\n\n\n\n\n\n\n“Joseph Rickert - R Consortium”\n“Paul Schuette - FDA”\n“Yilong Zhang - Merck”\n“Bob Engle - Biogen”\n“Chris Kania - Biogen”\n“Doug Kelkhoff - Genentech”\n“James Black - Roche”\n“Juliane Manitz - Emd Serono”\n“Mike Stackhouse - Atorus Research”\n“Nan Xiao - Merck”\n“Ning Leng - Genentech”\n“Ojesh Upandhyay GSK”\n“Phil Bowsher - RStudio”\n“Eric Nantz - Eli Lilly”\n\n\n\n\nJoseph Rickert began the meeting by noting that the Submisisons working group now has a GithHub Repo which contains the minutes and video recording from the first meeting. JR asked if there are external groups that we should involve. Michael Stackhouse and Paul Schuette suggest linking up with PHUSE. JR asks for a recommendation from PHUSE, MS offers to investigate.\nJR asked PS if he could elaborate on requirements from various government agencies. Paul recommends contacting Wendy Martinez of BLS, and leader of the Inter-Agency R Users Group.\nPS also notes that declining budgets in various government agencies are forcing declining budgets and that consequently there is a renewed interest in open source. There is particular interest in establishing a stable R environment and the whole panoply of tools required.\nJR noted that although other federal agencies are not directly involved in setting requirements for R submissions they must have some say in setting general requirements and technology standards and asked PS if he could elaborate on the hierarchy of federal agencies involved. PS stated that the government has a federated model. Groups tend to do their own thing. The FDA has some standards that are not uniformly enforced. They are center specific. CDER and CBER are the two centers that are most closely linked. Require CDISC heading towards STDTM, ADaM and other data standards. CDRH has a more heterogeneous sponsor group and even gets some submissions in Excel.\nCVM is in between. Other centers like CPT don’t much deal with clinical trials. Paul’s presentation (from last time) focused on CDER and CBER and the portals and gateways that have been set up there. Even within the his center the Office of Biostatistics does not control the standards FDA submissions gateway uses.\nThere are two different types of standards: there are the standards of CDISC and PHUSE and then there are the standards of “What does one have to do to actually submit through the electronics gateway”.\nEric Nantz asks if the group that is handling the gateway is also in CDER and CBER. PS replied that it is, but in a different office. (At 11:21 PS elaborates on which groups are involved.) The actual gateway is under the Office of Business Informatics which is in the Office of Strategic Programs. It is a Balkanized setup. Primary tool for clinicians in the Office of New Drugs is JMP clinical, script in Python, some code in SAS and R.\nAnything with inferential statistics falls to the Office of Biostatistics. Safety issues are mostly done elsewhere by clinicians.\nProject PORTES has a provision for a submissions portal and also includes turning XPT data sets into S or R data sets. PS recommends getting Ethan Chen involved, but in short term writing program that modifies scripts (e.g. from .lower case to .Upper case) would be faster approach.\nEN and PS note that the discussions last time (see the presentation by Yilong Zhang) made it clear that industry is already working on this approach and suggest that it may be worth pursuing.\nJR (22:29) suggested that we may want to pursue the idea of setting up a stable R environment. YZ says Merck is working on a package to assemble functions into a txt file, and stated that once they have a stable version they would be willing to discuss making it open source.\nJR suggests that going for a stable R environment would pull together several threads of work in progress, and asked if setting up a pilot server with an R environment configured similarly to an environment typically used for submissions would be helpful. PS said that he thought so and referenced (26:30) a project he and EN did a couple of years ago to stand up a stable snapshot.\nYZ argues for making a purely open source setup. YZ and EN suggest (48:30) that we could setup a repo with software to CDISC tables and synthetic data for a hypothetical submission and we could collaborate and show how it could scale to do a real submission.\nPS noted that a project he and Doug Kelkhoff worked on to use Docker had issues with mixing environment like Windows and Linux. PS noted that he is constrained to use a particular version of Windows 10.\nPS likes the idea of having a common repo that includes a class of standard packages. Mike Stackhouse notes that the problem is to have the right structure, packages and package management. MS notes that there are several package management solutions available\nJames Black asks Paul (33:00) how identical solutions have to be. There was some discussion about this. PS notes opinions vary between 100% identical and having results close enough so as not to change the decision. (e.g. p = 0.019 and p = 0.19 are clearly different, but there is a lot of gray area.)\nEN notes it is possible to lock down what goes into a container that would minimize risk even OS differences, but states that getting things stable at the R package level is the bigger issue. (There seemed to be general agreement about this.) DK says locking downing the R environment using packrat or rn would give us a foothold. If this is successful we could reproduce the same environment in a container.\nDK noted that many of difficulties he and PS had during previous FDA project had to do with mounting a file system and how data is accessed within the FDA. Suggests bundling packages with base environment.\nMS asked if part of project would be to show that the pilot gives same results in Windows and Linux. PS indicates that it would.\nJR notes that there is a consensus for a pilot, and states that even if pilot did not address everything it would be a good start, and asks those present to uses the repo to suggest ideas and contribute relevant documents.\n\nAction Items\nJR takes action items to reach out to:\n\nPHUSE\nWendy Martinez\nToma Drogen (ORA deals with field inspectors)\n\n\n\nNext meeting\nAll agree on 9AM Pacific Time February 5th.\n\n\nVideo Recording\nThe video recording of the meeting is available here The passcode is oM5YqkM\n\n\nNote from Doug Kelkhoff\nIn a private communication after the meeting Doug Kelkhoff contributed the following:\nAt today’s meeting, Paul mentioned a pilot that he and I worked on to share docker containers. It would be great if I could share that code with you all. I reached out to the lead from the PHUSE working group to see if we can get that code uploaded somewhere where I can share it.\nA brief summary of what was done:\n\nDelivery of a docker-compose build script, chosen for transparency and to adhere to plain-text restrictions of delivery content. It consisted of:\n\nbase image based on rocker shiny+tidyverse image\n\na small cohort of packages to install\na mock analysis and companion shiny app\ndata access (which ended up being the problematic piece of the puzzle)\n\nWe encountered a few data access woes:\n\nwe first attempted to mount a data directory within the eCTD, which prompted for escalated administrator privileges on windows machines - not an acceptable solution\nthe second attempt was to build the data into the container image, which we were unfortunately not able to fully test before Paul had to move on to other priorities.\n\n\nOverall, I still have confidence that this method could work, but, as Paul mentioned, the “it works on my machine” method of trying to debug across platforms and administrated systems is both frustrating and time intensive. Remotely teasing apart docker-related issues from system administration restrictions without a clear picture of the systems constraints was quite a challenge." }, { - "objectID": "dev_background.html", - "href": "dev_background.html", - "title": "Site Development", + "objectID": "minutes/2024-01-05/index.html", + "href": "minutes/2024-01-05/index.html", + "title": "Minutes 2024-01-05", "section": "", - "text": "The Submissions working group website is built using the Quarto scientific and technical publishing system based in markdown format and compiled with Pandoc." + "text": "View Attendee List\n\n\n\n\n\n\nBen Straub (GSK)\nDadong Zhang (Illumina)\nEva Li\nHeidi Curinckx (Johnson & Johnson)\nHyeSoo Cho (FDA)\nJoseph Rickert (R Consortium)\nMargaret Wishart\nNan Xiao (Merck)\nNing Leng (Roche/Genentech)\nPaul Schuette (FDA)\nRobert Devine (Johnson & Johnson)\nSaghir Bashir (Argenx)\nSam Parmar (Pfizer)\nSteven Hasendinckx (Johnson & Johnson)\nYoun Kyeong Chang\nThe meeting was recorded and the video is available." }, { - "objectID": "dev_background.html#overview", - "href": "dev_background.html#overview", - "title": "Site Development", + "objectID": "minutes/2024-01-05/index.html#pilot-3", + "href": "minutes/2024-01-05/index.html#pilot-3", + "title": "Minutes 2024-01-05", + "section": "Pilot 3", + "text": "Pilot 3\nHyeSoo presented an update on the continuing FDA evaluation of Pilot 3.\n\nUsing the R generated ADaM data sets, the FDA reviewers were able to replicate the results of the demographic, efficacy, primary and KM plot analyses\nThe reviewers compared the results of the four analyses between Pilot 1 and Pilot 3.\n\nPrimary output in Pilot 3 was different from the Pilot 1 result due to the QC findings\nQC findings in ADRG include all of the discrepancies between the original ADaM datasets\nThe discrepancies in ADADAS data sets cause different primary analyses outputs\nThis is an issue from the CDISC ADADAS\nIt is not clear which CDISC file, the file from Pilot 1 or the file from Pilot 3, is correct.\n\n\nThe following figure compares the Pilot 1 and Pilot 3 primary output. Discrepancies are highlighted.\n Additional FDA questions included:\n\nWhy is there an indication in the output of LOCF, “Last observation carried forward” when the original data set had no missing data?\nThere was no statistical analysis plan included in the submission.\nAction: Ben Straub will confer with the Pilot 3 team to answer these questions and review the discrepancy problems between Pilots 1 and 3.\nAction: Paul and HyeSoo will discuss whether we need to resubmit Pilot 3 The next meeting of the working group will be on Friday, February 2, 2024 at 9AM Pacific Time.\nAll agreed that if a resubmission of Pilot 3 is required, we will consider submitting via a .zip file.\n\nThere was some discussion about what we could do to improve the quality control of our submissions.\n\nThe group agreed that we should have a check list to compare items against a Pilot 1 source of truth.\nWe should have additional reviewers who are not close to the work.\nThe idea of using AI tools to check consistency was mentioned." + }, + { + "objectID": "minutes/2024-01-05/index.html#upcoming-webinar", + "href": "minutes/2024-01-05/index.html#upcoming-webinar", + "title": "Minutes 2024-01-05", + "section": "Upcoming Webinar", + "text": "Upcoming Webinar\nOn Monday at 7PM PST Rikimaru Nishimura and Yuki Matsunaga will present a webinar on The Adoption of R in Japan’s Pharma Industry Confirmation. Look here for details and information on how to register.\n\nNing noted that Yuki expressed an interest in collaborating with the R Consortium.\nAction: we will set up a meeting with the Japanese team after the meeting." + }, + { + "objectID": "minutes/2024-01-05/index.html#pharmasug", + "href": "minutes/2024-01-05/index.html#pharmasug", + "title": "Minutes 2024-01-05", + "section": "PharmaSUG", + "text": "PharmaSUG\n\nJBR mentioned that it is an R Consortium goal for 2024 to make the opportunity for as many speaking engagements as possible.\nBen mentioned that PharmaSUG 2024 is coming up in May,\nAction: Ben volunteered to submit an abstract by the January 15 deadline. Ning will provide Ben with some copy used for a previous abstract.\n\nThe next meeting of the working group will be at 9AM PST on Friday, February 2, 2024." + }, + { + "objectID": "minutes/2022-09-02/index.html", + "href": "minutes/2022-09-02/index.html", + "title": "Minutes 2022-09-02", "section": "", - "text": "The Submissions working group website is built using the Quarto scientific and technical publishing system based in markdown format and compiled with Pandoc." + "text": "View Attendee List\n\n\n\n\n\n\nBob Engle (Biogen)\nCG Wang\nDadong Zhang (Illumina)\nEllis Hughes (GSK)\nEric Nantz (Eli Lilly)\nGabriel Becker (Roche/Genentech)\nHeidi Curinckx (Johnson & Johnson)\nHelena Sviglin (FDA)\nHenry Wang (Roche/Genentech)\nJizu Zhi (FDA)\nJoseph Rickert (R Consortium)\nLei Zhao (Roche/Genentech)\nNan Xiao (Merck)\nNing Leng (Roche/Genentech)\nPaul Schuette (FDA)\nRenping Zhang (Johnson & Johnson)\nRobert Devine (Johnson & Johnson)\nRupam Bhattacharyya (University of Michigan)\nRyan Johnson (Posit)\nSaghir Bashir (Argenx)\nSam Parmar (Pfizer)\nSean Healey (Pfizer)\nThomas Neitmann (Roche/Genentech)\n\n\n\n\nThe meeting was recorded and the video is available.\n\nEMA\nJBR started the meeting by asking if thee was any news about the effort to submit to the European Health Authorities. Ning Leng replied that the European Medicines Agency announced a new pilot project where they will run a number of pilot studies over the next couple of years in which they will accept data and code. Ning said that her team discussed this with Chris Price of whose who said that the EMA would want to review real data. This appears to preclude the R Consortium from participating from this effort. However, the group agreed we would be happy to help a sponsor company submit an R pilot.\nAction Item if there is sponsor company interested in submitting R code as part of an EMA pilot project, the RC Submissions WG would be happy to help an participate in a shared learning.\n\n\nPilot 2\nNing Leng and Eric Nantz gave an update on the Pilot 2 project Eric is testing the Pilot 2 submission on Windows virtual machines using two version of R v4.1.2 and 4.2.0.\nPaul Schuette confirmed that the FDA team would prefer to keep the Pilot 2 deployment on a local machine and Eric said that the documentation is being written from that point of view.\nEric needs the RC credit card to proceed with the shinyapps.io deployment.\nAction Items\n\nEric would like help testing the Pilot 2 Windows deployment. WG members please help with the testing process.\nJBR will speak with Elisa Trevino to generate the credit card for the shinyapps.io setup.\n\n** Ning will email the WG when the submission documents are ready for review. WG members please help with this review.\nTarget Date for Pilot 2 Ning and Eric agreed that Monday, September 26, 2022 is the target date for the Pilot 2 submission.\n\n\nJapanese and Chinese Authorities\nNing believes that the companies are interested in proceeding with pilot R submissions but the authorities are reticent because they do not have the resources to review pilots.\nJBR commented that it appears that our pilot approach is not appropriate for China and Japan and ask the group to think about alternatives for approaching these authorities.\nPilot 3 Eric said that he recently spoke Martin Wimpress and authority in this area who strongly recommends podman which is considered an open source, binary equivalent to docker.\nThe group agreed that we should build a podman team that comprises representatives from at least two or three different companies as well as a representative from the FDA. Paul Schuette volunteered that he would ask his FDA management to assign someone to the team. T\nAction Item WG members please look within your companies to recruit people with the podman expertise for the Pilot 3 team. Paul noted that another FDA center has approval for podman and the it would take him a couple of months to obtain similar approval for his center. the WG would like to launch the container team at the October meeting.\n\n\nPilot 1 - adam\nNing introduced Thomas Neitmann and Joel Laxamana who are creating a proposal to construct a submission that would use the R to generate ADaM data from the cdisc data used in Pilots 1 and 2. The project would make use of the admiral R package.\nAction Item JBR will ask the RC to create two repositories under the R Consortium organization on GitHub: submissions-pilot1-adam-extension and submissions-pilot1-adam-extension-to-fda . Ideally the former would be a fork of the submissions-pilot1 repo and the latter a fork of the submissions-pilot1-to-fda repo.\n\n\nDescribe the Sturcture of Subgroups\nThere was a request to describe the Submission WG subgroups sufficiently for newcomers to find their way around. The main website for the subgroups is https://rconsortium.github.io/submissions-wg\nJBR asked the subgroup leaders to list all of the individuals who participated in the various subgroups, even those who may now be inactive.\nThe group agreed that it would be appropriate to keep a record of everyone who helped with the working group in order to recognize their contributions. We\nAction Item Subgroup leaders should list participants, and write a couple of sentences about how newcomers can get involved.\nThe next meeting of the submissions working group will be at 9AM Pacific Time on Friday, October 7, 2022." }, { - "objectID": "dev_background.html#development-setup", - "href": "dev_background.html#development-setup", - "title": "Site Development", - "section": "Development Setup", - "text": "Development Setup\nEnsure that you have Quarto version 1.2 or later installed on your development environment. More details on downloading and installing Quarto can be found in the Get Started guide.\nA recent version of R (4.1.2 or later) is sufficient. Ensure that you have the following R packages installed:\n\n{openxlsx2}\n{dplyr}\n\nIt is recommended to use the RStudio IDE (v2022.07 or later) as your development environment for building and rendering the web site. Refer to the Creating a Website guide details on the workflow." + "objectID": "minutes/2023-10-06/index.html", + "href": "minutes/2023-10-06/index.html", + "title": "Minutes 2023-10-06", + "section": "", + "text": "View Attendee List\n\n\n\n\n\n\nAndrew Borgman (Bristol Myers Squibb)\nBen Straub (GSK)\nEric Nantz (Eli Lilly)\nHyeSoo Cho (FDA)\nJizu Zhi (FDA)\nJoseph Rickert (R Consortium)\nKaushal Shah (ASU)\nNan Xiao (Merck)\nNing Leng (Roche/Genentech)\nPaul Schuette (FDA)\nRenping Zhang (Johnson & Johnson)\nRobert Devine (Johnson & Johnson)\nSaghir Bashir (Argenx)\nSam Parmar (Pfizer)\nYoun Kyeong Chang (FDA)\n\n\n\n\nThe meeting was recorded and the video is available.\n\nNew Member\nHyeSoo introduced Youn Kyeong Chang as a new member of the group who will be helping to evaluate the pilot submissions for the FDA.\n\n\nPilot 2\n\nJBR began the meeting by noting the successful conclusion of the Pilot 2 submission and commenting on the attention it is getting throughout the industry.\nThe group thanked Paul and HyeSoo for there work on the project and their efforts to shepherd the review through the FDA process.\nNing remarked that it was really helpful that Paul was able to provide us with the FDA letter for the ASA conference.\nNing and Eric talked about the how much attention their poster got at the conference.\nThe working group is enthusiastic about doing an R Consortium webinar about the Pilot 2 project.\nThe tentative date for the webinar is 3:00PM EST on Monday December 11, 2023.\nAction: Ning will prepare the letter requesting speakers for the FDA and contact the R Adoption series organizers.\nAction: JBR will also contact the R Consortium webinar production team.\n\n\n\nPilot 3\n\nHyeSoo laid out a timeline for evaluating Pilot 3, saying it would take an additional six to seven months to complete.\nBen said that there is quite a bit of interest at GSK about the ADRG because Pilot 3 did not use pkglite.\nHyeSoo remarked that the ADRG is different but that her preliminary look did not show any problems.\nThere was some discussion abut looking back at the ADRGs made for both Pilot 2 and Pilot 3.\nEric noted that he made the Pilot 2 ADRG in Quarto and was very happy with the workflow.\nWe can expect feedback on the review during our normal sessions.\nBen Staub noted that Novo Nordisk about presentation about their recent R submission.\nPaul remarked that he cannot comment on the Novo Nordisk submission since it is not finalized, but he did say that what Novo Nordisk said in their presentation about keeping things simple (limiting packages and dependencies) and being able to trace key endpoints is the same advice the FDA would be give.\nPaul also noted that the fact that the FDA is not able to comment on submissions in progress is one reason why it is nice to have a pilot.\n\n\n\nPilot 4\n\nEric reported that he had the opportunity with meet with the Appsilon folks helping with Pilot 4 at posit::conf and that next sprint on the project will begin this coming week.\nJBR brought up on several limitations to WebAssembly, such as not being able to accommodate networking functions in the browser.\nEric replied that Pilot 4 is not likely to hit the constraining limits, but that these may become a concern as we move into more robust submissions in 2024. (This discussion begins about 21:00 in the video)\nJBR asks that we take the trouble to communicate clearly about our knowledge of the limitations.\nThere was a discussion about whether the FDA would be ready to receive a container based sub-submission.\nThe agreed that Pilot 4 in two parts: part a will be WebAssembly based and part b sill be based on containers.\nEric believes that he will be ready to submit Part 4.a in mid December. Paul will confer with his management about resources being available in that time frame.\nThere was a discussion about whether setting up a server with containers outside of the FDA would we be helpful for FDA reviewers becoming familiar with Podman.\nJBR remarked that other working groups are interested in establishing protocols, best practices, and requirements for repositories.\nPaul noted that from the FDA’s point of view, longevity should be a requirement noting that 6 years would be a minimum and there may be reasons to consider 20 years.\nThe group decided that it would be feasible and may be helpful to set up a server with the Pilot 2 submission shiny app running in a container.\n\n\n\nParticipation in the ISBS 7th Symposium\n\nJBR mentioned that he received an an invitation from Qi, Hong hong_qi@merck.com, the organizer of the The 7th International Symposium on Biopharmaceutical Statistics to present a 20 minute talk at the event. The invitation is below.\nLink to ISBS past event\nThe group agreed that we should try to participate even though it seems to be a primarily statistician driven event.\nNing offered to put together an abstract.\nPending some final investigation, JBR will let them know that we would like to participate but that we do not yet know who the speaker will be.\nJBR noted that it might be an opportunity to present the FDA’s view about the kind of statistics and principles that govern an FDA submission.\n\n\n\nFDASA Proposal\n\nNing has prepared a final version of the abstract for a session solely from the R Consortium.\nJoe will send the proposal in a with a cover letter to Paul.\nThe ASA Biopharma working group intends to send its own proposal for a talk.\n\nThe next meeting of the working group will be at 9AM PST on Friday November 3, 2023.\n\n\nInvitation from ISBS\nDear Joseph,\nThanks so much for expressing interest in presenting at The 7th International Symposium on Biopharmaceutical Statistics, which will take place on March 6 – 9, 2024, at Hilton Baltimore Inner Harbor. The symposium is organized by the International Society for Biopharmaceutical Statistics (ISBS). Prominent statisticians and drug development professionals from regulatory agencies, academia, and industry will deliver keynote speeches on various emerging/evolving fields. Invited and contributed presentations will cover a wide range of topics including innovative statistics, clinical development, regulatory science, and data science.\nWe are organizing a Regulatory Submission session dedicated to communicating the agencies’ requirements for drug submission, and the implementation of industry standards to support the acquisition, exchange, analysis, submission and archival of clinical data and metadata in the pharmaceutical industry. We cordially invite you to present an R topic related to regulatory submission. Each presentation has 20 minutes including speech and Q&A. It is highly appreciated if you may provide the presentation topic and presenter(s)’ name by October 15, 2023. Below are the important dates:\nAbstract submission due: Oct. 29th, 2023. Registration start date: Nov. 15th, 2023. Presentation slides due: Feb. 15th, 2024. Sincerely,\nMary Varughese, Chair Hong Qi, Organizer\nRegulatory Submission Session\n7th Symposium, ISBS" }, { - "objectID": "dev_background.html#site-organization", - "href": "dev_background.html#site-organization", - "title": "Site Development", - "section": "Site Organization", - "text": "Site Organization\nMost of the site uses standard configurations outlined in the websites guide. Below are additional details for developing site content based on the type of material:\n\nPilots\nEach pilot conducted by this working group has its own dedicated page and associated quarto file named pilotX.qmd where X denotes the index of the pilot. High-level descriptions of all pilots is stored in pilot_background.qmd.\n\n\nWorking Group Minutes\nThe site uses the blog feature to create a custom listing for working group meeting minutes with all files stored in the minutes directory. Within the minutes directory, create a directory with the date of the working group meeting (for example 2023-01-23) and within this directory, create a quarto document named index.qmd. Visit the Minutes Draft Gen page for an interactive way of creating a new Quarto document file used for a future working group meeting minutes, including an easy way to assemble the attendees present at the meeting." + "objectID": "pilot3.html", + "href": "pilot3.html", + "title": "R Submission Pilot 3", + "section": "", + "text": "Goals:\n\nExpand on the work done in Submission Pilot 1, by now utilizing R to generate ADaM datasets.\nDeliver a publicly accessible R-based Submission to the FDA\n\nKey evaluation aspects:\n\nFor Submitter\n\nGeneration of a reproducible R environment with a proprietary R package from git and open source R packages using {renv}\nPreparation of R-based submission materials\n\nFor FDA Staff\n\nReproduce analysis results by reproducing the R environment and retrieving both proprietary & open source packages\n\n\nTimeline:\n\nSubmitted to FDA on August 28th, 2023\nFeedback from FDA on February 2nd, 2024 (See feedback here)\nRe-submitted to FDA on April 19th, 2024\n\nData and analysis scope:\n\nADaMs created using R (SDTM .xpt sourced from the CDISC Pilot study)\nTLFs created using R (ADaMs .xpt sourced from the ADaMs generated in R by the Pilot 3 team)\n\nLinks:\nR Submission Pilot 3 Development Repo\n\nDevelopment area for Pilot 3 Team\nSee Closed Issues discussion for how we worked\nSee Wiki for Common Issues we ran into and QC Findings we encountered when comparing the ADaMs generated in the CDISC Pilot study.\nWe made use of a GitHub Project Board (Kanban Style Board) to drive development.\n\nR Submission Pilot 3 eCTD Submission Package to FDA\n\nMaterials submitted to the FDA following eCTD standards\n\nR Submission Pilot 3 Website\n\nBreakdown of the Github repositories and files used for analysis development, e-submission and proprietary Pilot 3 R Package\nRenderings of ADaMs, TLFs, ADRG and Cover Letter\nDiscussions at Conferences and feedback from FDA\n\nKey team members:\nDeveloper team:\n\nJoel Laxamana-Roche\nThomas Neitmann-Denali\nPhanikumar Tata-Syneos\nRobert Devine-J&J\nSteven Haesendonckx-J&J\nLei Zhao-Roche\nNicole Jones-Denali\nKangjie Zhang-Bayer\nBenjamin Straub-GSK\nDeclan Hodges-GSK\nBingjun Wang - Merck\n\nFDA Staff:\n\nPaul Schuette\n\nHye Soo Cho" }, { - "objectID": "pilot_background.html", - "href": "pilot_background.html", - "title": "Background", + "objectID": "pilot2.html", + "href": "pilot2.html", + "title": "R Submission Pilot 2", "section": "", - "text": "Provide open examples of submitting R-based clinical trial data/analysis packages to FDA.\n\nAll pilots will be submitted from R consortium (non-profit identity) to FDA. Simulated data will be used.\nAll data, codes and documents will be fully available to public.\nFDA Staff will be engaged to reproduce analysis results.\nSubmitter and FDA Staff will provide feedback on current process/system\nContributions from multiple companies/organizations are preferred. Avoid bias to any company/organization specific tools.\n\nYou can view more details about each of the current pilots by visiting their dedicated pages below:\n\nPilot 1: Common analyses\nPilot 2: Shiny application submission\nPilot 3: ADaM datasets\nPilot 4: Alternative formats" + "text": "Goal: Example R based submission contains a shiny app, submission through the current FDA e-submission system and process\nKey evaluation aspects:\n\nFor Submitter\n\nSubmission of an shiny app through the eCTD portal\nThe shiny codes will be provided as a proprietary R package\n\nFor FDA Reviewer\n\nReproduce analysis results by deploying the shiny app on a FDA laptop/server\n\n\nTimeline: 2022 H1\nData and analysis scope:\n\na shiny app that displays the 4 TLFs submitted in pilot 1, with basic data set filtering functionalities.\nSimulated data from CDISC Pilot (the same data set as in pilot 1)\n\nLinks:\nR Submission Pilot 2 Development Repo\nR Submission Pilot 2 eCTD Submission Package to FDA\nKey team members:\nDeveloper team:\n- Ning Leng, Heng Wang (Roche)\n- Mike Stakehouse, Eli Miller (Atorus)\n- Yilong Zhang, Gregery Chen (Merck)\n- Eric Nantz (Eli Lilly)\nFDA Staff:\n- Paul Schuette\n- Hye Soo Cho" }, { - "objectID": "pilot_background.html#pilot-principles", - "href": "pilot_background.html#pilot-principles", - "title": "Background", + "objectID": "pilot2.html#pilot-2---shiny-submission", + "href": "pilot2.html#pilot-2---shiny-submission", + "title": "R Submission Pilot 2", "section": "", - "text": "Provide open examples of submitting R-based clinical trial data/analysis packages to FDA.\n\nAll pilots will be submitted from R consortium (non-profit identity) to FDA. Simulated data will be used.\nAll data, codes and documents will be fully available to public.\nFDA Staff will be engaged to reproduce analysis results.\nSubmitter and FDA Staff will provide feedback on current process/system\nContributions from multiple companies/organizations are preferred. Avoid bias to any company/organization specific tools.\n\nYou can view more details about each of the current pilots by visiting their dedicated pages below:\n\nPilot 1: Common analyses\nPilot 2: Shiny application submission\nPilot 3: ADaM datasets\nPilot 4: Alternative formats" + "text": "Goal: Example R based submission contains a shiny app, submission through the current FDA e-submission system and process\nKey evaluation aspects:\n\nFor Submitter\n\nSubmission of an shiny app through the eCTD portal\nThe shiny codes will be provided as a proprietary R package\n\nFor FDA Reviewer\n\nReproduce analysis results by deploying the shiny app on a FDA laptop/server\n\n\nTimeline: 2022 H1\nData and analysis scope:\n\na shiny app that displays the 4 TLFs submitted in pilot 1, with basic data set filtering functionalities.\nSimulated data from CDISC Pilot (the same data set as in pilot 1)\n\nLinks:\nR Submission Pilot 2 Development Repo\nR Submission Pilot 2 eCTD Submission Package to FDA\nKey team members:\nDeveloper team:\n- Ning Leng, Heng Wang (Roche)\n- Mike Stakehouse, Eli Miller (Atorus)\n- Yilong Zhang, Gregery Chen (Merck)\n- Eric Nantz (Eli Lilly)\nFDA Staff:\n- Paul Schuette\n- Hye Soo Cho" }, { - "objectID": "about.html", - "href": "about.html", - "title": "About", + "objectID": "index.html", + "href": "index.html", + "title": "Introduction", "section": "", - "text": "About this site\n\n1 + 1\n\n[1] 2" + "text": "Welcome to the R Consortium R Submission Working Group!\nThe R submission working group is a cross industry pharma working group focusing on improving practices of R-based clinical trial regulatory submissions.\nYou can view previous meeting minutes with links to recorded sessions in the navigation bar above.\n\nOur Mission\n\nEasier R-based clinical trial regulatory submissions today\n\nby showing open examples of using current submission portals\n\nEasier R-based clinical trial regulatory submissions tomorrow\n\nby collecting feedback and influencing future industry and agency decisions on system/process setup" }, { "objectID": "faq.html", @@ -378,263 +399,298 @@ "text": "About the R consortium R submission working group\n\nWho can join the working group? How can I get involved?\n\n\nanyone can join the working group. The working group meets monthly on Friday. If you are interested in joining the monthly meetings, please contact Joe Rickert at joseph.rickert@rstudio.com.\nYou can also monitor our issue board. Any contribution/feedback are more than welcome" }, { - "objectID": "index.html", - "href": "index.html", - "title": "Introduction", + "objectID": "about.html", + "href": "about.html", + "title": "About", "section": "", - "text": "Welcome to the R Consortium R Submission Working Group!\nThe R submission working group is a cross industry pharma working group focusing on improving practices of R-based clinical trial regulatory submissions.\nYou can view previous meeting minutes with links to recorded sessions in the navigation bar above.\n\nOur Mission\n\nEasier R-based clinical trial regulatory submissions today\n\nby showing open examples of using current submission portals\n\nEasier R-based clinical trial regulatory submissions tomorrow\n\nby collecting feedback and influencing future industry and agency decisions on system/process setup" + "text": "About this site\n\n1 + 1\n\n[1] 2" }, { - "objectID": "pilot2.html", - "href": "pilot2.html", - "title": "R Submission Pilot 2", + "objectID": "pilot_background.html", + "href": "pilot_background.html", + "title": "Background", "section": "", - "text": "Goal: Example R based submission contains a shiny app, submission through the current FDA e-submission system and process\nKey evaluation aspects:\n\nFor Submitter\n\nSubmission of an shiny app through the eCTD portal\nThe shiny codes will be provided as a proprietary R package\n\nFor FDA Reviewer\n\nReproduce analysis results by deploying the shiny app on a FDA laptop/server\n\n\nTimeline: 2022 H1\nData and analysis scope:\n\na shiny app that displays the 4 TLFs submitted in pilot 1, with basic data set filtering functionalities.\nSimulated data from CDISC Pilot (the same data set as in pilot 1)\n\nLinks:\nR Submission Pilot 2 Development Repo\nR Submission Pilot 2 eCTD Submission Package to FDA\nKey team members:\nDeveloper team:\n- Ning Leng, Heng Wang (Roche)\n- Mike Stakehouse, Eli Miller (Atorus)\n- Yilong Zhang, Gregery Chen (Merck)\n- Eric Nantz (Eli Lilly)\nFDA Staff:\n- Paul Schuette\n- Hye Soo Cho" + "text": "Provide open examples of submitting R-based clinical trial data/analysis packages to FDA.\n\nAll pilots will be submitted from R consortium (non-profit identity) to FDA. Simulated data will be used.\nAll data, codes and documents will be fully available to public.\nFDA Staff will be engaged to reproduce analysis results.\nSubmitter and FDA Staff will provide feedback on current process/system\nContributions from multiple companies/organizations are preferred. Avoid bias to any company/organization specific tools.\n\nYou can view more details about each of the current pilots by visiting their dedicated pages below:\n\nPilot 1: Common analyses\nPilot 2: Shiny application submission\nPilot 3: ADaM datasets\nPilot 4: Alternative formats" }, { - "objectID": "pilot2.html#pilot-2---shiny-submission", - "href": "pilot2.html#pilot-2---shiny-submission", - "title": "R Submission Pilot 2", + "objectID": "pilot_background.html#pilot-principles", + "href": "pilot_background.html#pilot-principles", + "title": "Background", "section": "", - "text": "Goal: Example R based submission contains a shiny app, submission through the current FDA e-submission system and process\nKey evaluation aspects:\n\nFor Submitter\n\nSubmission of an shiny app through the eCTD portal\nThe shiny codes will be provided as a proprietary R package\n\nFor FDA Reviewer\n\nReproduce analysis results by deploying the shiny app on a FDA laptop/server\n\n\nTimeline: 2022 H1\nData and analysis scope:\n\na shiny app that displays the 4 TLFs submitted in pilot 1, with basic data set filtering functionalities.\nSimulated data from CDISC Pilot (the same data set as in pilot 1)\n\nLinks:\nR Submission Pilot 2 Development Repo\nR Submission Pilot 2 eCTD Submission Package to FDA\nKey team members:\nDeveloper team:\n- Ning Leng, Heng Wang (Roche)\n- Mike Stakehouse, Eli Miller (Atorus)\n- Yilong Zhang, Gregery Chen (Merck)\n- Eric Nantz (Eli Lilly)\nFDA Staff:\n- Paul Schuette\n- Hye Soo Cho" + "text": "Provide open examples of submitting R-based clinical trial data/analysis packages to FDA.\n\nAll pilots will be submitted from R consortium (non-profit identity) to FDA. Simulated data will be used.\nAll data, codes and documents will be fully available to public.\nFDA Staff will be engaged to reproduce analysis results.\nSubmitter and FDA Staff will provide feedback on current process/system\nContributions from multiple companies/organizations are preferred. Avoid bias to any company/organization specific tools.\n\nYou can view more details about each of the current pilots by visiting their dedicated pages below:\n\nPilot 1: Common analyses\nPilot 2: Shiny application submission\nPilot 3: ADaM datasets\nPilot 4: Alternative formats" }, { - "objectID": "pilot3.html", - "href": "pilot3.html", - "title": "R Submission Pilot 3", + "objectID": "dev_background.html", + "href": "dev_background.html", + "title": "Site Development", "section": "", - "text": "Goals:\n\nExpand on the work done in Submission Pilot 1, by now utilizing R to generate ADaM datasets.\nDeliver a publicly accessible R-based Submission to the FDA\n\nKey evaluation aspects:\n\nFor Submitter\n\nGeneration of a reproducible R environment with a proprietary R package from git and open source R packages using {renv}\nPreparation of R-based submission materials\n\nFor FDA Staff\n\nReproduce analysis results by reproducing the R environment and retrieving both proprietary & open source packages\n\n\nTimeline:\n\nSubmitted to FDA on August 28th, 2023\nFeedback from FDA on February 2nd, 2024 (See feedback here)\nRe-submitted to FDA on April 19th, 2024\n\nData and analysis scope:\n\nADaMs created using R (SDTM .xpt sourced from the CDISC Pilot study)\nTLFs created using R (ADaMs .xpt sourced from the ADaMs generated in R by the Pilot 3 team)\n\nLinks:\nR Submission Pilot 3 Development Repo\n\nDevelopment area for Pilot 3 Team\nSee Closed Issues discussion for how we worked\nSee Wiki for Common Issues we ran into and QC Findings we encountered when comparing the ADaMs generated in the CDISC Pilot study.\nWe made use of a GitHub Project Board (Kanban Style Board) to drive development.\n\nR Submission Pilot 3 eCTD Submission Package to FDA\n\nMaterials submitted to the FDA following eCTD standards\n\nR Submission Pilot 3 Website\n\nBreakdown of the Github repositories and files used for analysis development, e-submission and proprietary Pilot 3 R Package\nRenderings of ADaMs, TLFs, ADRG and Cover Letter\nDiscussions at Conferences and feedback from FDA\n\nKey team members:\nDeveloper team:\n\nJoel Laxamana-Roche\nThomas Neitmann-Denali\nPhanikumar Tata-Syneos\nRobert Devine-J&J\nSteven Haesendonckx-J&J\nLei Zhao-Roche\nNicole Jones-Denali\nKangjie Zhang-Bayer\nBenjamin Straub-GSK\nDeclan Hodges-GSK\nBingjun Wang - Merck\n\nFDA Staff:\n\nPaul Schuette\n\nHye Soo Cho" + "text": "The Submissions working group website is built using the Quarto scientific and technical publishing system based in markdown format and compiled with Pandoc." }, { - "objectID": "minutes/2023-10-06/index.html", - "href": "minutes/2023-10-06/index.html", - "title": "Minutes 2023-10-06", + "objectID": "dev_background.html#overview", + "href": "dev_background.html#overview", + "title": "Site Development", "section": "", - "text": "View Attendee List\n\n\n\n\n\n\nAndrew Borgman (Bristol Myers Squibb)\nBen Straub (GSK)\nEric Nantz (Eli Lilly)\nHyeSoo Cho (FDA)\nJizu Zhi (FDA)\nJoseph Rickert (R Consortium)\nKaushal Shah (ASU)\nNan Xiao (Merck)\nNing Leng (Roche/Genentech)\nPaul Schuette (FDA)\nRenping Zhang (Johnson & Johnson)\nRobert Devine (Johnson & Johnson)\nSaghir Bashir (Argenx)\nSam Parmar (Pfizer)\nYoun Kyeong Chang (FDA)\n\n\n\n\nThe meeting was recorded and the video is available.\n\nNew Member\nHyeSoo introduced Youn Kyeong Chang as a new member of the group who will be helping to evaluate the pilot submissions for the FDA.\n\n\nPilot 2\n\nJBR began the meeting by noting the successful conclusion of the Pilot 2 submission and commenting on the attention it is getting throughout the industry.\nThe group thanked Paul and HyeSoo for there work on the project and their efforts to shepherd the review through the FDA process.\nNing remarked that it was really helpful that Paul was able to provide us with the FDA letter for the ASA conference.\nNing and Eric talked about the how much attention their poster got at the conference.\nThe working group is enthusiastic about doing an R Consortium webinar about the Pilot 2 project.\nThe tentative date for the webinar is 3:00PM EST on Monday December 11, 2023.\nAction: Ning will prepare the letter requesting speakers for the FDA and contact the R Adoption series organizers.\nAction: JBR will also contact the R Consortium webinar production team.\n\n\n\nPilot 3\n\nHyeSoo laid out a timeline for evaluating Pilot 3, saying it would take an additional six to seven months to complete.\nBen said that there is quite a bit of interest at GSK about the ADRG because Pilot 3 did not use pkglite.\nHyeSoo remarked that the ADRG is different but that her preliminary look did not show any problems.\nThere was some discussion abut looking back at the ADRGs made for both Pilot 2 and Pilot 3.\nEric noted that he made the Pilot 2 ADRG in Quarto and was very happy with the workflow.\nWe can expect feedback on the review during our normal sessions.\nBen Staub noted that Novo Nordisk about presentation about their recent R submission.\nPaul remarked that he cannot comment on the Novo Nordisk submission since it is not finalized, but he did say that what Novo Nordisk said in their presentation about keeping things simple (limiting packages and dependencies) and being able to trace key endpoints is the same advice the FDA would be give.\nPaul also noted that the fact that the FDA is not able to comment on submissions in progress is one reason why it is nice to have a pilot.\n\n\n\nPilot 4\n\nEric reported that he had the opportunity with meet with the Appsilon folks helping with Pilot 4 at posit::conf and that next sprint on the project will begin this coming week.\nJBR brought up on several limitations to WebAssembly, such as not being able to accommodate networking functions in the browser.\nEric replied that Pilot 4 is not likely to hit the constraining limits, but that these may become a concern as we move into more robust submissions in 2024. (This discussion begins about 21:00 in the video)\nJBR asks that we take the trouble to communicate clearly about our knowledge of the limitations.\nThere was a discussion about whether the FDA would be ready to receive a container based sub-submission.\nThe agreed that Pilot 4 in two parts: part a will be WebAssembly based and part b sill be based on containers.\nEric believes that he will be ready to submit Part 4.a in mid December. Paul will confer with his management about resources being available in that time frame.\nThere was a discussion about whether setting up a server with containers outside of the FDA would we be helpful for FDA reviewers becoming familiar with Podman.\nJBR remarked that other working groups are interested in establishing protocols, best practices, and requirements for repositories.\nPaul noted that from the FDA’s point of view, longevity should be a requirement noting that 6 years would be a minimum and there may be reasons to consider 20 years.\nThe group decided that it would be feasible and may be helpful to set up a server with the Pilot 2 submission shiny app running in a container.\n\n\n\nParticipation in the ISBS 7th Symposium\n\nJBR mentioned that he received an an invitation from Qi, Hong hong_qi@merck.com, the organizer of the The 7th International Symposium on Biopharmaceutical Statistics to present a 20 minute talk at the event. The invitation is below.\nLink to ISBS past event\nThe group agreed that we should try to participate even though it seems to be a primarily statistician driven event.\nNing offered to put together an abstract.\nPending some final investigation, JBR will let them know that we would like to participate but that we do not yet know who the speaker will be.\nJBR noted that it might be an opportunity to present the FDA’s view about the kind of statistics and principles that govern an FDA submission.\n\n\n\nFDASA Proposal\n\nNing has prepared a final version of the abstract for a session solely from the R Consortium.\nJoe will send the proposal in a with a cover letter to Paul.\nThe ASA Biopharma working group intends to send its own proposal for a talk.\n\nThe next meeting of the working group will be at 9AM PST on Friday November 3, 2023.\n\n\nInvitation from ISBS\nDear Joseph,\nThanks so much for expressing interest in presenting at The 7th International Symposium on Biopharmaceutical Statistics, which will take place on March 6 – 9, 2024, at Hilton Baltimore Inner Harbor. The symposium is organized by the International Society for Biopharmaceutical Statistics (ISBS). Prominent statisticians and drug development professionals from regulatory agencies, academia, and industry will deliver keynote speeches on various emerging/evolving fields. Invited and contributed presentations will cover a wide range of topics including innovative statistics, clinical development, regulatory science, and data science.\nWe are organizing a Regulatory Submission session dedicated to communicating the agencies’ requirements for drug submission, and the implementation of industry standards to support the acquisition, exchange, analysis, submission and archival of clinical data and metadata in the pharmaceutical industry. We cordially invite you to present an R topic related to regulatory submission. Each presentation has 20 minutes including speech and Q&A. It is highly appreciated if you may provide the presentation topic and presenter(s)’ name by October 15, 2023. Below are the important dates:\nAbstract submission due: Oct. 29th, 2023. Registration start date: Nov. 15th, 2023. Presentation slides due: Feb. 15th, 2024. Sincerely,\nMary Varughese, Chair Hong Qi, Organizer\nRegulatory Submission Session\n7th Symposium, ISBS" + "text": "The Submissions working group website is built using the Quarto scientific and technical publishing system based in markdown format and compiled with Pandoc." }, { - "objectID": "minutes/2022-09-02/index.html", - "href": "minutes/2022-09-02/index.html", - "title": "Minutes 2022-09-02", - "section": "", - "text": "View Attendee List\n\n\n\n\n\n\nBob Engle (Biogen)\nCG Wang\nDadong Zhang (Illumina)\nEllis Hughes (GSK)\nEric Nantz (Eli Lilly)\nGabriel Becker (Roche/Genentech)\nHeidi Curinckx (Johnson & Johnson)\nHelena Sviglin (FDA)\nHenry Wang (Roche/Genentech)\nJizu Zhi (FDA)\nJoseph Rickert (R Consortium)\nLei Zhao (Roche/Genentech)\nNan Xiao (Merck)\nNing Leng (Roche/Genentech)\nPaul Schuette (FDA)\nRenping Zhang (Johnson & Johnson)\nRobert Devine (Johnson & Johnson)\nRupam Bhattacharyya (University of Michigan)\nRyan Johnson (Posit)\nSaghir Bashir (Argenx)\nSam Parmar (Pfizer)\nSean Healey (Pfizer)\nThomas Neitmann (Roche/Genentech)\n\n\n\n\nThe meeting was recorded and the video is available.\n\nEMA\nJBR started the meeting by asking if thee was any news about the effort to submit to the European Health Authorities. Ning Leng replied that the European Medicines Agency announced a new pilot project where they will run a number of pilot studies over the next couple of years in which they will accept data and code. Ning said that her team discussed this with Chris Price of whose who said that the EMA would want to review real data. This appears to preclude the R Consortium from participating from this effort. However, the group agreed we would be happy to help a sponsor company submit an R pilot.\nAction Item if there is sponsor company interested in submitting R code as part of an EMA pilot project, the RC Submissions WG would be happy to help an participate in a shared learning.\n\n\nPilot 2\nNing Leng and Eric Nantz gave an update on the Pilot 2 project Eric is testing the Pilot 2 submission on Windows virtual machines using two version of R v4.1.2 and 4.2.0.\nPaul Schuette confirmed that the FDA team would prefer to keep the Pilot 2 deployment on a local machine and Eric said that the documentation is being written from that point of view.\nEric needs the RC credit card to proceed with the shinyapps.io deployment.\nAction Items\n\nEric would like help testing the Pilot 2 Windows deployment. WG members please help with the testing process.\nJBR will speak with Elisa Trevino to generate the credit card for the shinyapps.io setup.\n\n** Ning will email the WG when the submission documents are ready for review. WG members please help with this review.\nTarget Date for Pilot 2 Ning and Eric agreed that Monday, September 26, 2022 is the target date for the Pilot 2 submission.\n\n\nJapanese and Chinese Authorities\nNing believes that the companies are interested in proceeding with pilot R submissions but the authorities are reticent because they do not have the resources to review pilots.\nJBR commented that it appears that our pilot approach is not appropriate for China and Japan and ask the group to think about alternatives for approaching these authorities.\nPilot 3 Eric said that he recently spoke Martin Wimpress and authority in this area who strongly recommends podman which is considered an open source, binary equivalent to docker.\nThe group agreed that we should build a podman team that comprises representatives from at least two or three different companies as well as a representative from the FDA. Paul Schuette volunteered that he would ask his FDA management to assign someone to the team. T\nAction Item WG members please look within your companies to recruit people with the podman expertise for the Pilot 3 team. Paul noted that another FDA center has approval for podman and the it would take him a couple of months to obtain similar approval for his center. the WG would like to launch the container team at the October meeting.\n\n\nPilot 1 - adam\nNing introduced Thomas Neitmann and Joel Laxamana who are creating a proposal to construct a submission that would use the R to generate ADaM data from the cdisc data used in Pilots 1 and 2. The project would make use of the admiral R package.\nAction Item JBR will ask the RC to create two repositories under the R Consortium organization on GitHub: submissions-pilot1-adam-extension and submissions-pilot1-adam-extension-to-fda . Ideally the former would be a fork of the submissions-pilot1 repo and the latter a fork of the submissions-pilot1-to-fda repo.\n\n\nDescribe the Sturcture of Subgroups\nThere was a request to describe the Submission WG subgroups sufficiently for newcomers to find their way around. The main website for the subgroups is https://rconsortium.github.io/submissions-wg\nJBR asked the subgroup leaders to list all of the individuals who participated in the various subgroups, even those who may now be inactive.\nThe group agreed that it would be appropriate to keep a record of everyone who helped with the working group in order to recognize their contributions. We\nAction Item Subgroup leaders should list participants, and write a couple of sentences about how newcomers can get involved.\nThe next meeting of the submissions working group will be at 9AM Pacific Time on Friday, October 7, 2022." + "objectID": "dev_background.html#development-setup", + "href": "dev_background.html#development-setup", + "title": "Site Development", + "section": "Development Setup", + "text": "Development Setup\nEnsure that you have Quarto version 1.2 or later installed on your development environment. More details on downloading and installing Quarto can be found in the Get Started guide.\nA recent version of R (4.1.2 or later) is sufficient. Ensure that you have the following R packages installed:\n\n{openxlsx2}\n{dplyr}\n\nIt is recommended to use the RStudio IDE (v2022.07 or later) as your development environment for building and rendering the web site. Refer to the Creating a Website guide details on the workflow." }, { - "objectID": "minutes/2024-01-05/index.html", - "href": "minutes/2024-01-05/index.html", - "title": "Minutes 2024-01-05", + "objectID": "dev_background.html#site-organization", + "href": "dev_background.html#site-organization", + "title": "Site Development", + "section": "Site Organization", + "text": "Site Organization\nMost of the site uses standard configurations outlined in the websites guide. Below are additional details for developing site content based on the type of material:\n\nPilots\nEach pilot conducted by this working group has its own dedicated page and associated quarto file named pilotX.qmd where X denotes the index of the pilot. High-level descriptions of all pilots is stored in pilot_background.qmd.\n\n\nWorking Group Minutes\nThe site uses the blog feature to create a custom listing for working group meeting minutes with all files stored in the minutes directory. Within the minutes directory, create a directory with the date of the working group meeting (for example 2023-01-23) and within this directory, create a quarto document named index.qmd. Visit the Minutes Draft Gen page for an interactive way of creating a new Quarto document file used for a future working group meeting minutes, including an easy way to assemble the attendees present at the meeting." + }, + { + "objectID": "pilot1.html", + "href": "pilot1.html", + "title": "R Submission Pilot 1", "section": "", - "text": "View Attendee List\n\n\n\n\n\n\nBen Straub (GSK)\nDadong Zhang (Illumina)\nEva Li\nHeidi Curinckx (Johnson & Johnson)\nHyeSoo Cho (FDA)\nJoseph Rickert (R Consortium)\nMargaret Wishart\nNan Xiao (Merck)\nNing Leng (Roche/Genentech)\nPaul Schuette (FDA)\nRobert Devine (Johnson & Johnson)\nSaghir Bashir (Argenx)\nSam Parmar (Pfizer)\nSteven Hasendinckx (Johnson & Johnson)\nYoun Kyeong Chang\nThe meeting was recorded and the video is available." + "text": "Goal: Example R based submission contains common analyses, submission through the current FDA e-submission system and process.\nKey evaluation aspects:\n\nFor Submitter\n\nSubmission of proprietary R packages\nPreparation of R-based submission materials\n\nFor FDA Staff\n\nReproduce analysis results by reconstructing submitted proprietary packages / retrieving open source packages\n\n\nData and analysis scope:\n\n4 TLFs\nSimulated data from CDISC Pilot\n\nSuccess Criteria:\n\nSubmitter:\n\nSuccessfully submit via eCTD portal\n\nFDA Reviewer:\n\nReproduce analysis results\n\n\nTimeline: - Submitted 2021 Nov (v0.1.0) - FDA first response 2021 Nov - Resubmission 2022 Feb (v0.1.0)\nLinks:\nR Submission Pilot 1 Development Repo\nR Submission Pilot 1 eCTD Submission Package to FDA\nAdditional Activities - explore pilot submissions to other HAs (Japan, China)\nKey team members:\nDeveloper team:\n- Ning Leng, Heng Wang (Roche)\n- Mike Stakehouse, Eli Miller (Atorus)\n- Yilong Zhang, Peikun Wu (Merck)\nEsub team:\n- Beverly Chin (Roche)\n- Tim Powell (Biogen)\nFDA Staff:\n- Paul Schuette\n- Hye Soo Cho" }, { - "objectID": "minutes/2024-01-05/index.html#pilot-3", - "href": "minutes/2024-01-05/index.html#pilot-3", - "title": "Minutes 2024-01-05", - "section": "Pilot 3", - "text": "Pilot 3\nHyeSoo presented an update on the continuing FDA evaluation of Pilot 3.\n\nUsing the R generated ADaM data sets, the FDA reviewers were able to replicate the results of the demographic, efficacy, primary and KM plot analyses\nThe reviewers compared the results of the four analyses between Pilot 1 and Pilot 3.\n\nPrimary output in Pilot 3 was different from the Pilot 1 result due to the QC findings\nQC findings in ADRG include all of the discrepancies between the original ADaM datasets\nThe discrepancies in ADADAS data sets cause different primary analyses outputs\nThis is an issue from the CDISC ADADAS\nIt is not clear which CDISC file, the file from Pilot 1 or the file from Pilot 3, is correct.\n\n\nThe following figure compares the Pilot 1 and Pilot 3 primary output. Discrepancies are highlighted.\n Additional FDA questions included:\n\nWhy is there an indication in the output of LOCF, “Last observation carried forward” when the original data set had no missing data?\nThere was no statistical analysis plan included in the submission.\nAction: Ben Straub will confer with the Pilot 3 team to answer these questions and review the discrepancy problems between Pilots 1 and 3.\nAction: Paul and HyeSoo will discuss whether we need to resubmit Pilot 3 The next meeting of the working group will be on Friday, February 2, 2024 at 9AM Pacific Time.\nAll agreed that if a resubmission of Pilot 3 is required, we will consider submitting via a .zip file.\n\nThere was some discussion about what we could do to improve the quality control of our submissions.\n\nThe group agreed that we should have a check list to compare items against a Pilot 1 source of truth.\nWe should have additional reviewers who are not close to the work.\nThe idea of using AI tools to check consistency was mentioned." + "objectID": "pilot1.html#pilot-1---common-analyses", + "href": "pilot1.html#pilot-1---common-analyses", + "title": "R Submission Pilot 1", + "section": "", + "text": "Goal: Example R based submission contains common analyses, submission through the current FDA e-submission system and process.\nKey evaluation aspects:\n\nFor Submitter\n\nSubmission of proprietary R packages\nPreparation of R-based submission materials\n\nFor FDA Staff\n\nReproduce analysis results by reconstructing submitted proprietary packages / retrieving open source packages\n\n\nData and analysis scope:\n\n4 TLFs\nSimulated data from CDISC Pilot\n\nSuccess Criteria:\n\nSubmitter:\n\nSuccessfully submit via eCTD portal\n\nFDA Reviewer:\n\nReproduce analysis results\n\n\nTimeline: - Submitted 2021 Nov (v0.1.0) - FDA first response 2021 Nov - Resubmission 2022 Feb (v0.1.0)\nLinks:\nR Submission Pilot 1 Development Repo\nR Submission Pilot 1 eCTD Submission Package to FDA\nAdditional Activities - explore pilot submissions to other HAs (Japan, China)\nKey team members:\nDeveloper team:\n- Ning Leng, Heng Wang (Roche)\n- Mike Stakehouse, Eli Miller (Atorus)\n- Yilong Zhang, Peikun Wu (Merck)\nEsub team:\n- Beverly Chin (Roche)\n- Tim Powell (Biogen)\nFDA Staff:\n- Paul Schuette\n- Hye Soo Cho" }, { - "objectID": "minutes/2024-01-05/index.html#upcoming-webinar", - "href": "minutes/2024-01-05/index.html#upcoming-webinar", - "title": "Minutes 2024-01-05", - "section": "Upcoming Webinar", - "text": "Upcoming Webinar\nOn Monday at 7PM PST Rikimaru Nishimura and Yuki Matsunaga will present a webinar on The Adoption of R in Japan’s Pharma Industry Confirmation. Look here for details and information on how to register.\n\nNing noted that Yuki expressed an interest in collaborating with the R Consortium.\nAction: we will set up a meeting with the Japanese team after the meeting." + "objectID": "pilot4.html", + "href": "pilot4.html", + "title": "R Submission Pilot 4", + "section": "", + "text": "Goal: Utilize alternative methods of distributing a self-contained submission bundle of the Pilot 2 Shiny application with container and web-assembly technologies.\nKey evaluation aspects:\n\nFor Submitter\n\nGeneration of a reproducible execution environment containing both the system and R-specific dependencies using Podman as the container runtime.\nGeneration of a web-assembly version of the Pilot 2 Shiny application (with small modifications) that can be executed in an existing R process running a web server using the {httpuv} R package\nPreparation of submission materials with detailed instructions on setting up the execution environments\n\nFor FDA Staff\n\nReproduce the ability to use the Shiny application by building the specific Podman container and viewing the web-assembly version of the application using the Edge internet browser.\n\n\nTimeline: Targeting a first submission in Q2 2024\nData and analysis scope:\n\nA shiny app that replicates most of the functionality from the pilot 2, with small modifications to account for the web-assembly constraints.\nSimulated data from CDISC Pilot (the same data set as in pilot 1)\n\nLinks:\nR Submission Pilot 4 Container Development Repository\nR Submission Pilot 4 Web-Assembly App Repository\nKey team members\nDeveloper team:\n\nEric Nantz (Eli Lilly)\nSam Parmar (Pfizer)\nPedro Silva (Appsilon)\nIsmael Rodgriguez (Appsilon)\nAndre Verissimo (Appsilon)\nRobert Devine (J&J)\nNate Mockler (Biogen)\nAndrew Borgman (Bristol Myers Squibb)\nBen Straub (GSK)\n\nFDA Staff:\n\nPaul Schutte\nHye Soo Cho" }, { - "objectID": "minutes/2024-01-05/index.html#pharmasug", - "href": "minutes/2024-01-05/index.html#pharmasug", - "title": "Minutes 2024-01-05", - "section": "PharmaSUG", - "text": "PharmaSUG\n\nJBR mentioned that it is an R Consortium goal for 2024 to make the opportunity for as many speaking engagements as possible.\nBen mentioned that PharmaSUG 2024 is coming up in May,\nAction: Ben volunteered to submit an abstract by the January 15 deadline. Ning will provide Ben with some copy used for a previous abstract.\n\nThe next meeting of the working group will be at 9AM PST on Friday, February 2, 2024." + "objectID": "minutes_prep.html", + "href": "minutes_prep.html", + "title": "Minutes Document Writer", + "section": "", + "text": "This interactive page creates a template Quarto document text for capturing meeting minutes associated with the Submissions working group.\n\n\nUse the date input below to choose the date of the meeting. Click the calendar icon in the widget to launch the UI.\n\nviewof meeting_date = Inputs.date({\n label: \"Meeting Date\",\n value: \"2023-02-01\"\n})\n\n\n\n\n\n\n\nmeeting_year = (meeting_date.getFullYear()).toString()\nmeeting_month = (meeting_date.getMonth() + 1).toString().padStart(2, \"0\")\nmeeting_day = (meeting_date.getDate() + 1).toString().padStart(2, \"0\")\n\nmeeting_array = [meeting_year, meeting_month, meeting_day]\nmeeting_print = meeting_array.join(\"-\")\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nUse the personnel table below to select the attendees present at the meeting by checking the box that appears once you hover your cursor above a name. The table is ordered alphabetically by first name as default, but you can sort by a different column by clicking the column name.\n\n\n\n\n\n\nWarning\n\n\n\nIf an attendee is not listed in this table, please add their name, affiliation, and affiliation URL to the wg_attendees.xlsx spreadsheet located in the data subdirectory of this repository. After your edits to the spreadsheet are completed, re-build the Quarto site.\n\n\n\ndata2 = transpose(people_data)\n\n\n\n\n\n\n\nviewof people_selection = Inputs.table(data2, {\n sort: \"name\",\n multiple: true,\n rows: 40,\n required: false\n})" }, { - "objectID": "minutes/2021-01-15/index.html", - "href": "minutes/2021-01-15/index.html", - "title": "Minutes 2021-01-15", + "objectID": "minutes_prep.html#date-selection", + "href": "minutes_prep.html#date-selection", + "title": "Minutes Document Writer", "section": "", - "text": "View Attendee List\n\n\n\n\n\n\n“Joseph Rickert - R Consortium”\n“Paul Schuette - FDA”\n“Yilong Zhang - Merck”\n“Bob Engle - Biogen”\n“Chris Kania - Biogen”\n“Doug Kelkhoff - Genentech”\n“James Black - Roche”\n“Juliane Manitz - Emd Serono”\n“Mike Stackhouse - Atorus Research”\n“Nan Xiao - Merck”\n“Ning Leng - Genentech”\n“Ojesh Upandhyay GSK”\n“Phil Bowsher - RStudio”\n“Eric Nantz - Eli Lilly”\n\n\n\n\nJoseph Rickert began the meeting by noting that the Submisisons working group now has a GithHub Repo which contains the minutes and video recording from the first meeting. JR asked if there are external groups that we should involve. Michael Stackhouse and Paul Schuette suggest linking up with PHUSE. JR asks for a recommendation from PHUSE, MS offers to investigate.\nJR asked PS if he could elaborate on requirements from various government agencies. Paul recommends contacting Wendy Martinez of BLS, and leader of the Inter-Agency R Users Group.\nPS also notes that declining budgets in various government agencies are forcing declining budgets and that consequently there is a renewed interest in open source. There is particular interest in establishing a stable R environment and the whole panoply of tools required.\nJR noted that although other federal agencies are not directly involved in setting requirements for R submissions they must have some say in setting general requirements and technology standards and asked PS if he could elaborate on the hierarchy of federal agencies involved. PS stated that the government has a federated model. Groups tend to do their own thing. The FDA has some standards that are not uniformly enforced. They are center specific. CDER and CBER are the two centers that are most closely linked. Require CDISC heading towards STDTM, ADaM and other data standards. CDRH has a more heterogeneous sponsor group and even gets some submissions in Excel.\nCVM is in between. Other centers like CPT don’t much deal with clinical trials. Paul’s presentation (from last time) focused on CDER and CBER and the portals and gateways that have been set up there. Even within the his center the Office of Biostatistics does not control the standards FDA submissions gateway uses.\nThere are two different types of standards: there are the standards of CDISC and PHUSE and then there are the standards of “What does one have to do to actually submit through the electronics gateway”.\nEric Nantz asks if the group that is handling the gateway is also in CDER and CBER. PS replied that it is, but in a different office. (At 11:21 PS elaborates on which groups are involved.) The actual gateway is under the Office of Business Informatics which is in the Office of Strategic Programs. It is a Balkanized setup. Primary tool for clinicians in the Office of New Drugs is JMP clinical, script in Python, some code in SAS and R.\nAnything with inferential statistics falls to the Office of Biostatistics. Safety issues are mostly done elsewhere by clinicians.\nProject PORTES has a provision for a submissions portal and also includes turning XPT data sets into S or R data sets. PS recommends getting Ethan Chen involved, but in short term writing program that modifies scripts (e.g. from .lower case to .Upper case) would be faster approach.\nEN and PS note that the discussions last time (see the presentation by Yilong Zhang) made it clear that industry is already working on this approach and suggest that it may be worth pursuing.\nJR (22:29) suggested that we may want to pursue the idea of setting up a stable R environment. YZ says Merck is working on a package to assemble functions into a txt file, and stated that once they have a stable version they would be willing to discuss making it open source.\nJR suggests that going for a stable R environment would pull together several threads of work in progress, and asked if setting up a pilot server with an R environment configured similarly to an environment typically used for submissions would be helpful. PS said that he thought so and referenced (26:30) a project he and EN did a couple of years ago to stand up a stable snapshot.\nYZ argues for making a purely open source setup. YZ and EN suggest (48:30) that we could setup a repo with software to CDISC tables and synthetic data for a hypothetical submission and we could collaborate and show how it could scale to do a real submission.\nPS noted that a project he and Doug Kelkhoff worked on to use Docker had issues with mixing environment like Windows and Linux. PS noted that he is constrained to use a particular version of Windows 10.\nPS likes the idea of having a common repo that includes a class of standard packages. Mike Stackhouse notes that the problem is to have the right structure, packages and package management. MS notes that there are several package management solutions available\nJames Black asks Paul (33:00) how identical solutions have to be. There was some discussion about this. PS notes opinions vary between 100% identical and having results close enough so as not to change the decision. (e.g. p = 0.019 and p = 0.19 are clearly different, but there is a lot of gray area.)\nEN notes it is possible to lock down what goes into a container that would minimize risk even OS differences, but states that getting things stable at the R package level is the bigger issue. (There seemed to be general agreement about this.) DK says locking downing the R environment using packrat or rn would give us a foothold. If this is successful we could reproduce the same environment in a container.\nDK noted that many of difficulties he and PS had during previous FDA project had to do with mounting a file system and how data is accessed within the FDA. Suggests bundling packages with base environment.\nMS asked if part of project would be to show that the pilot gives same results in Windows and Linux. PS indicates that it would.\nJR notes that there is a consensus for a pilot, and states that even if pilot did not address everything it would be a good start, and asks those present to uses the repo to suggest ideas and contribute relevant documents.\n\nAction Items\nJR takes action items to reach out to:\n\nPHUSE\nWendy Martinez\nToma Drogen (ORA deals with field inspectors)\n\n\n\nNext meeting\nAll agree on 9AM Pacific Time February 5th.\n\n\nVideo Recording\nThe video recording of the meeting is available here The passcode is oM5YqkM\n\n\nNote from Doug Kelkhoff\nIn a private communication after the meeting Doug Kelkhoff contributed the following:\nAt today’s meeting, Paul mentioned a pilot that he and I worked on to share docker containers. It would be great if I could share that code with you all. I reached out to the lead from the PHUSE working group to see if we can get that code uploaded somewhere where I can share it.\nA brief summary of what was done:\n\nDelivery of a docker-compose build script, chosen for transparency and to adhere to plain-text restrictions of delivery content. It consisted of:\n\nbase image based on rocker shiny+tidyverse image\n\na small cohort of packages to install\na mock analysis and companion shiny app\ndata access (which ended up being the problematic piece of the puzzle)\n\nWe encountered a few data access woes:\n\nwe first attempted to mount a data directory within the eCTD, which prompted for escalated administrator privileges on windows machines - not an acceptable solution\nthe second attempt was to build the data into the container image, which we were unfortunately not able to fully test before Paul had to move on to other priorities.\n\n\nOverall, I still have confidence that this method could work, but, as Paul mentioned, the “it works on my machine” method of trying to debug across platforms and administrated systems is both frustrating and time intensive. Remotely teasing apart docker-related issues from system administration restrictions without a clear picture of the systems constraints was quite a challenge." + "text": "Use the date input below to choose the date of the meeting. Click the calendar icon in the widget to launch the UI.\n\nviewof meeting_date = Inputs.date({\n label: \"Meeting Date\",\n value: \"2023-02-01\"\n})\n\n\n\n\n\n\n\nmeeting_year = (meeting_date.getFullYear()).toString()\nmeeting_month = (meeting_date.getMonth() + 1).toString().padStart(2, \"0\")\nmeeting_day = (meeting_date.getDate() + 1).toString().padStart(2, \"0\")\n\nmeeting_array = [meeting_year, meeting_month, meeting_day]\nmeeting_print = meeting_array.join(\"-\")" }, { - "objectID": "minutes/2023-04-07/index.html", - "href": "minutes/2023-04-07/index.html", - "title": "Minutes 2023-04-07", + "objectID": "minutes_prep.html#attendee-selection", + "href": "minutes_prep.html#attendee-selection", + "title": "Minutes Document Writer", "section": "", - "text": "View Attendee List\n\n\n\n\n\n\nAmanda Martin\nAndrew Borgman (Bristol Myers Squibb)\nBen Straub (GSK)\nHeidi Curinckx (Johnson & Johnson)\nHyeSoo Cho (FDA)\nJoel Laxamana (Roche/Genentech)\nKui Schen (Bayer)\nLei Zhao (Roche/Genentech)\nNan Xiao (Merck)\nNate Mockler (Biogen)\nNing Leng (Roche/Genentech)\nPaul Schuette (FDA)\nRobert Devine (Johnson & Johnson)\nSaghir Bashir (Argenx)\nSam Parmar (Pfizer)\nSean Healey (Pfizer)" + "text": "Use the personnel table below to select the attendees present at the meeting by checking the box that appears once you hover your cursor above a name. The table is ordered alphabetically by first name as default, but you can sort by a different column by clicking the column name.\n\n\n\n\n\n\nWarning\n\n\n\nIf an attendee is not listed in this table, please add their name, affiliation, and affiliation URL to the wg_attendees.xlsx spreadsheet located in the data subdirectory of this repository. After your edits to the spreadsheet are completed, re-build the Quarto site.\n\n\n\ndata2 = transpose(people_data)\n\n\n\n\n\n\n\nviewof people_selection = Inputs.table(data2, {\n sort: \"name\",\n multiple: true,\n rows: 40,\n required: false\n})" }, { - "objectID": "minutes/2023-04-07/index.html#pilot-2-update", - "href": "minutes/2023-04-07/index.html#pilot-2-update", - "title": "Minutes 2023-04-07", - "section": "Pilot 2 Update", - "text": "Pilot 2 Update\nEric Nantz provided the following update:\n\nHe has solved the filtering bug and has verified the app is working correctly with additional testing.\nHe is incorporating ADRG material into the intro guide\nPaul suggested adding a list of steps and has offered to discuss details offline.\nNing will work with Bev to make sure we are good to go with the gateway\nThe Pilot 2 re submission is set for 9AM on Friday, April 21, 2023. Joe will schedule the meeting (Bev, Eric, Hye Soo, Paul, Ning)" + "objectID": "minutes_prep.html#setup", + "href": "minutes_prep.html#setup", + "title": "Minutes Document Writer", + "section": "Setup", + "text": "Setup\nIn your local copy of this repository, create a sub-directory within the minutes directory to hold files associated with this meeting’s minutes. Based on your selection above, create the following directory:\n\nmeeting_print\n\n\n\n\n\n\nCopy the text in the output below into a new Quarto document named index.qmd.\n\nsilly = html`${Array.from(new Set(people_selection.map(c => c.name2)))\n.sort()\n.map(c => `- ${c}`)\n.join(\"\\n\")}`\n\nsilly2 = html`<pre>---\ntitle: \"Minutes ${meeting_print}\"\ndate: ${meeting_print}\n---\n\n::: {.callout-tip collapse=\"true\"}\n## View Attendee List\n\n${silly}:::\n\n## Add Minutes Here\n\n</pre>`\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nsilly2" }, { - "objectID": "minutes/2023-04-07/index.html#pilot-3-progress-update", - "href": "minutes/2023-04-07/index.html#pilot-3-progress-update", - "title": "Minutes 2023-04-07", - "section": "Pilot 3 Progress Update", - "text": "Pilot 3 Progress Update\nJoel Laxamana provided the following update.\n\nAll 5 ADaMs now generated and in review.\nPer development steps, we have noted discrepancies or findings when comparing our Pilot 3 ADaMs with the original Pilot 1 ADaMs. You may see these noted in our Wiki here : https://github.com/RConsortium/submissions-pilot3-adam/wiki/QC-Findings .\nMinor updates are being made to clean up code, updating our variable labels appropriately and updating the ADaM specifications (define) to meet CDISC guidance as we go through our routine P21 checks.\nWe are also currently developing our ADRG based off of the Pilot 3 specifications we are reading into P21. We plan to use the P21 ADRG as a base, then we will add in information similar to that of Pilot 1 for complete instructions prior to submission.\nAs we finalize both the define and the ADaMs, we are also developing a batch run code to run all of our ADaM and TLF scripts, with that we are looking into implementing dependency recognition using a package called {targets} (e.g. before ADAE is run, checks latest ADSL code has been run first).\n\nAdditionally, we are rerunning all TFL scripts from Pilot 1 and re-sourcing the Pilot 3 data.\nOnce the above is finalized, we will do a batch run, check against P21, then bring everything over into our eSubmission repo. We have made contact with Roche’s Regulatory function who will help support the preparation of our eSubmission in eCTD structure.\n\n\nCurrent Project workflow discussion as seen in Pilot 1:\n\nUpon reviewing Pilot1’s work and the R4CSR guidance they have followed, we see the current flow suggests the use of 2 repos : 1)Project repo & 2)Submission repo\nIn the project repo, this includes the project analysis R scripts (ADaMs and TFLs) and R utility functions within the same package.\n14.2.2 programs\nFolder path: ectddemo/m5/datasets/ectddemo/analysis/adam/programs/.\nr0pkgs.txt: contains all internally developed proprietary R packages. Other .txt files: each contains R code for a specific analysis.\nThey also suggest using .RMD files as the source analysis scripts, which are then converted to .R/.txt for submission.\nThen all .txt are brought over to the Submission repo to deliver to Regulatory for eCTD structure and formal submission to the FDA portal.\n\nIn Pilot 3 our project flow emulates more of the usual project work we would see in our companies.\n\nFor instance, our source code will just use plain .R instead of .RMD as source analysis code. Especially for ADaMs, it make more sense to just start in .R scripts.\nFor the most part Pilot3 will follow the same submission process as Pilot1, but the minor difference will just be our project flow. I.E., Pilot 3 will separate the Utility functions from the Project analysis scripts into different repos. It makes more sense to treat the study specific utility functions as separate package, similar to how we call on other R packages from CRAN or other git repositories, where then the project analysis repo scripts will call on the aforementioned study specific utility functions package. This is still in line with the R4CSR guidance in section 14.3\n\nFollowing this approach, makes it clear from a study perspective where the utility functions are being called from, where the project analysis scripts are stored and developed and where the submission will be. For illustration purposes we have this graphic (Thanks, Thomas Neitman!):\n\n\n\nProposed Pilot 3 Repo Setup\n\n\n\nOverall, to our Health Agencies, the single source of truth will of course come from our ‘Submission’ repo, where they may not need all of the details of the study project flow steps. We just wanted to be able to discern that R packages should be kept in their own packages and project analysis work should not be stored as a package.\n\n\nPOST Meeting notes/actions from R Consortium Submissions WG (07Apr2023) :\n\nPer Paul Schutter, Pilot 3 needs a link to the ‘FREE’ P21 version that the Pilot 3 team should be using. Paul to share link with Joel. We should also include SDTM in the P21 run, but just mention in the ADRG that we will not be updating or fixing the SDTMs due to any P21 issues to follow the same approach as Pilot 1. Though Pilot 3 is mainly focused on ADaMs, we do plan on fixing the P21 issues the best we can and noting discrepancies compared to the CDISCPILOT data.\nNeed new repo from submission_wg to store the utility functions into. Joe R, could you help us with this?\nFor the study project repo set-up, there are example template repos that can be followed. Pilot 3 team to look into this.\nTargeting mid-June 2023 to wrap-up submission.\nLink to all Pilot 3 members, for Eric to include in Submission WG webpage : https://rconsortium.github.io/submissions-pilot3-adam/main/" + "objectID": "minutes/2024-04-05/Index.html", + "href": "minutes/2024-04-05/Index.html", + "title": "Minutes 2024-04-05", + "section": "", + "text": "View Attendee List\n\n\n\n\n\n\nBen Straub (GSK)\nEric Nantz (Eli Lilly)\nGregory Chen (MSD)\nHeidi Curinckx (Johnson & Johnson)\nHyeSoo Cho (FDA)\nJizu Zhi (FDA)\nJoseph Rickert (R Consortium)\nNan Xiao (Merck)\nNing Leng (Roche/Genentech)\nPaul Schuette (FDA)\nRobert Devine (Johnson & Johnson)\nSaghir Bashir (Argenx)\nSam Parmar (Pfizer)\nKangjie Zhang (Bayer)\nYoun Kyeon Chang (FDA)\nThe meeting was recorded and the video is available." }, { - "objectID": "minutes/2023-04-07/index.html#pilot-4", - "href": "minutes/2023-04-07/index.html#pilot-4", - "title": "Minutes 2023-04-07", + "objectID": "minutes/2024-04-05/Index.html#pilot-3-update", + "href": "minutes/2024-04-05/Index.html#pilot-3-update", + "title": "Minutes 2024-04-05", + "section": "Pilot 3 Update", + "text": "Pilot 3 Update\nBen Staub provided an update on Pilot 3\n\nThe Pilot 3 team is ready to make the resubmission.\nThe team will make the submission on Friday, April 12.\nNing will alert Bev at Roche who tests the gateway connection and makes the actual submission.\nIf all goes well, we expect the FDA could produce an evaluation report in late June or early July." + }, + { + "objectID": "minutes/2024-04-05/Index.html#pilot-4", + "href": "minutes/2024-04-05/Index.html#pilot-4", + "title": "Minutes 2024-04-05", "section": "Pilot 4", - "text": "Pilot 4\nEric Nantz gave a brief update:\n\nEric is starting to build a team and already has some volunteers\nThe effort will focus on container technology\nPaul Schuette will reach out within the FDA to find an FDA participant for this group\nPaul noted that anything having to do with servers would necessarily involve the use of contractors and have to have a budget.\nThere may be a way to have the container run on a laptop and thus avoid the complications caused by servers. *Ning Leng asked Paul if there are any other groups within the FDA that might be interested in pilots. Paul replied that the guidance he has received from management is to hold off on this for the time being." + "text": "Pilot 4\nEric Nantz reported on the Plot 4 effort. (9:11 into the video)\n\nWASAM Version\nEric asked for guidance on the placement of the zip file containing the application source files in the eCTD bundle. The WG decided that the placement indicated in the figure below looks fine.\n The ADRG will provide instructions for running the application. The workflow will be something like:\n\nUnzip the file\nExecute the functions provided to compile the WASM application\nExecute the functions provided to run the application. Two versions of execution functions will be provided:\n\n\nFunctions to execute with WASM\nFunctions to run a normal Shiny app as in Pilot 2\n\nDecisions were made:\n\nto continue zip files for M5, and not M#, even though this may throw a low level error.\nto keep the datasets in a sub directory of the directory containing the WASM code without having to copy them into a another location before building the app.\n\nA question was asked about what persists on the workstation when the browser is closed. The answer was: not much persists on the machine. It may be the case that some information is cached but nothing is written to the disk.\nA question was asked about having a short cut to launch the application. The answer is that in the current state of WebAssembly it is necessary to start a new R session (or other process) that can serve static files.\nAlso note the the process that spins up WebAssebly installs the required R packages. Unfortunately, with the current state of the technology there is no way to snapshot the versions of the packages.\n\n\nContainer Version\n\nA major development at the FDA is that FDA IT rejected the request to use Podman, but recommended that we use Docker.\nEric will include instructions in the ADRG to setup and run Docker containers." }, { - "objectID": "minutes/2023-04-07/index.html#asa-webinar", - "href": "minutes/2023-04-07/index.html#asa-webinar", - "title": "Minutes 2023-04-07", - "section": "ASA Webinar", - "text": "ASA Webinar\nJBR Informed the WG that the ASA New Jersey Chapter has contacted him about doing a webinar on the Submissions WG. The email below outlines a list of options.\n\nThe WG was enthusiastic about doing a robust webinar with multiple talks sometime after the Pilot 2 submission in June.\nPaul said that he would like to participate and asked if other ASA members could attend. Paul noted that he has had requests to speak from pharma companies, but it is difficult for FDA speakers to speak to individual companies without committing to speak to all companies.\nThe WG would like to co-brand the event as an R Adoption Series Event\n\n\nMarch 26, 2023 email from Sciling Ruan\nHi Joe,\nIt was very nice to speak to you last week and learned about what you do in the R-Submission working group. As discussed, we are very interested in collaborating with you to bring the topic of R-submission to our webinar. I also include our ASA NJ Chapter President Dirk Moore in the loop. Dirk is a faculty member in Rutgers University, and he will also help organize the webinar.\nI understand that you will need to discuss this collaboration within your working group. I would like to give more information in case it might be helpful.\nThe webinar can have one presentation or multiple presentations with different perspectives. So I would be interested to know the tentative presentation titles and speakers.\nThe webinar can be set in any date and month. We are very flexible. Normally, to accommodate both east coast and west coast audience, we often recommend the time slot of 11:00-12:00 or till 1:00 EDT on a Friday.\nWe might invite another speaker from a pharma company on their experience with R-submission (if we could identify a good speaker). In that case, the webinar will be two hours with a panel discussion. Will this set up OK with you? Once I have some information to work with, we will follow up with a kickoff meeting including all potential speakers to work out the details. The webinar will use the WebEx platform in Rutgers University. It will be a free event to everyone.\nI look forward to hearing from you. If you need more information from me, please let me know.\nBest regards, Shiling Ruan\n\n\nAdditional Conferences\nIn general, the WG is keen about promoting their work after the submission of Pilot 2 and the group discussed possible opportunities for talks alter this year including the R / Pharma conference and possibly and FDA event. The group will discuss this at the next meeting.\nThe next meeting of the WG will be at 9AM Pacific Time on Friday May 5, 2023." + "objectID": "minutes/2024-04-05/Index.html#communication-and-documentation", + "href": "minutes/2024-04-05/Index.html#communication-and-documentation", + "title": "Minutes 2024-04-05", + "section": "Communication and Documentation", + "text": "Communication and Documentation\n\nJoe pointed out the infrastructure developed by the Submissions working group is significant and complex and that it is difficult to explain. He asked if we should undertake an effort to expand the website to include materials to explain the processes and technology to newcomers and document the history of what has been done.\nNing suggested that we follow the lead of the R Valid Hub and look for a communications manager or assemble a small team.\nEric noted that we have been focused on the submission itself and do not want to take on the challenge of how companies might establish their internal environments. All agreed with this.\nJoe pointed out that the fact that Ning was chatting with Doug Kelkhoff is a good sign that there seems to be sufficient communication among the working groups to keep the working groups focused and avoid duplication.\nSam suggested putting a start here page and time line on the webpage. For example, see the NEST Timeline.\nEric noted that there might be a quarto extension to do a time line.\nA suggestion was made to compile all of our presentation.\nThe WG will open an issue on the submission-wg repository to collect ideas\nhe R for Clinical Study Reports and Submission website might serve as a model.\n\n\nActions\nJoe will:\n\ncompile suggestions for improving the website\nSee what help the RC marketing team can provide\nstart looking for a communications manager" }, { - "objectID": "minutes/2023-03-03/index.html", - "href": "minutes/2023-03-03/index.html", - "title": "Minutes 2023-03-03", + "objectID": "minutes/2024-04-05/Index.html#conference-presentations", + "href": "minutes/2024-04-05/Index.html#conference-presentations", + "title": "Minutes 2024-04-05", + "section": "Conference Presentations", + "text": "Conference Presentations\n\npharmaSUG - May 19 to 24\n\nAppsilon is planing a presentation on Pilot 4 work: SS-376 : Experimenting with Containers and webR for Submissions to FDA in the Pilot 4, André Veríssimo and Ismael Rodriguez Appsilon of Appsilon.\nSS-344 : Piloting into the Future: Publicly available R-based Submissions to the FDA by Benjamin Straub, GlaxoSmithKline\n\nUseR! 2024\n\nNing has submitted an abstract about Submissions WG work\n\nNing and Eric will be presenting at the DIA webinar\n\n\nActions\n\nJoe will ask RC marketing to prepare an RC slide for Sam and Appsilon to use in their presentations\nNing will provide the details on the DIA webinar so we can promote it." + }, + { + "objectID": "minutes/2024-04-05/Index.html#recommended-r-versions", + "href": "minutes/2024-04-05/Index.html#recommended-r-versions", + "title": "Minutes 2024-04-05", + "section": "Recommended R Versions", + "text": "Recommended R Versions\nIt turns out that making a recommendation for the version of R for companies to used in their submissions that would best harmonize with the versions that are likely to be in use at the FDA is much harder than we anticipated. Even our phrase for identifying our recommendation “Last patch version of the previous subversion” is not without ambiguity.\n\nIt is likely that each company will have its own approach to managing versions for submissions\nOur new goal is to see if we can make an R Consortium recommendation that has sufficient industry support.\nThe FDA would like to avoid the extremes:\n\nSubmissions using very old R versions\nSubmissions using the latest R development version\n\nThe FDA would also like to have submissions that are likely to still be available over a six year horizon. (FDA retention rules are six years.)\nNing proposed a series of posts from different companies on how they deal with versioning.\nAfter we have published a few posts we will survey the industry.\n\n\nAction\n\nNing will draft a post on the Roche approach\nJoe will have R Consortium Marketing produce the post" + }, + { + "objectID": "minutes/2024-04-05/Index.html#next-meeting", + "href": "minutes/2024-04-05/Index.html#next-meeting", + "title": "Minutes 2024-04-05", + "section": "Next meeting", + "text": "Next meeting\nThe next meeting of he working group will be on Friday, May 3, 2024 at 9AM Pacific Time." + }, + { + "objectID": "minutes/2021-09-03/index.html", + "href": "minutes/2021-09-03/index.html", + "title": "Minutes 2021-09-03", "section": "", - "text": "View Attendee List\n\n\n\n\n\n\nBen Straub (GSK)\nEric Nantz (Eli Lilly)\nHyeSoo Cho (FDA)\nJoel Laxamana (Roche/Genentech)\nJoseph Rickert (R Consortium)\nKui Schen (Bayer)\nLei Zhao (Roche/Genentech)\nNan Xiao (Merck)\nPaul Schuette (FDA)\nRenping Zhang (Johnson & Johnson)\nRobert Devine (Johnson & Johnson)\nSaghir Bashir (Argenx)\nSam Parmar (Pfizer)\nSean Healey (Pfizer)\n\n\n\n\nThe meeting was recorded and the video is available.\nDue to a problem with zoom permissions, the meeting started 15 minutes late. Apologize to everyone who was inconvenienced.\n(At 1:37 into the video) HyeSoo Cho begins sharing here screen and providing her comments on the recent Pilot 2 submission.\nA bug in the submission code caused population subsetting in the Kaplan Meier Curve to propagate silently throughout the shiny app. During the course of the meeting Eric Nantz was able to identify the problem as a incorrectly set option and correct it.\nJBR noted that turning off subgrouping for everything but the KM plot was a special requirement for the pilot submission and asked if under normal operation whether the FDA reviewers would like the shiny app to display this default behavior. (The alternative would be for app users to remember to turn on the same subgrouping for every plot or table in order to make comparisons.) HeySoo and Paul Schuette provided an explanation of the FDA’s need to be very careful of subgroup analysis.\nPaul emphasized that it is very important to distinguish between “exploratory analysis” and analysis for “inferential analysis”. Subgrouping that causes p-values to change cross the line between the two types of analyses. The FDA is very concerned that the misuse of subgrouping could lead people to improperly argue for evidence of efficacy based on restricted subpopulations. When asked if he was advising that submissions should not contain interactive capabilities Paul replied “No”. He elaborated that nothing interactive should produce a p-value.\n(10:48 into the video) Ning Leng asked if subpopulation analyses associated with predefined endpoints would be permissible as this would distinguish between inferential and exploratory analyses. Paul replied this is correct. He noted that prespecified subgroup analyses will often product confidence intervals but not p-values.\n(At 19:56) Eric announced the resolution to the parameter problem and the group agreed that we have a path forward for the current Pilot 2 submission. Eric also suggested that the interactivity may be the biggest topic for the group to discuss. Paul asked to defer the discussion of this bigger issue and suggested that the working group look to the ASA statement on p-values for guidance.\n(18:36) The FDA does not want to be seen as endorsing the practice of rescuing a “failed” clinical trial by torturing the data. He noted that even now there is a problem with JMP and other tools that that are interactive but do not produce an open and fully transparent analysis true.\nInteractive tool must be open, transparent, reproducible, and consistent with good statistical practices. Paul suggested that an interactive tool that produces interactive tools on demand may not be consistent with the ASA statement on p-values.\nIn response to a question, Paul affirmed that the ASA statement in p-values is a good foundation for understanding FDA practices.\n(22:57) Begins a discussion on shinymeta and reproducibility. It as also noted that the teal project is also addressing this reproducibility issue.\n(27:43) HeySoo resumes her comments on the Pilot 2 submission by commenting on the warning and error messages generated by the submission code, and points out that referencing a repository other than CRAN is problematic. Paul noted that FDA IT security is insisting on strong security checks, but that a case can be made that CRAN provides sufficient checks. He said that his group at the FDA is floating the notion of “curated” packages.\nHeySoo suggested that providing a README file that discusses all the potential error and warning messages and what needs to be done to run the app properly. Paul noted that some of this information should be included in the app to make it as stand alone as possible.\nThe working group agreed that the next step should be to produce an updated Pilot 2 submission package and resubmit it through the gateway. This will make it for the FDA to produce a written response. We will proceed with Pilot 2 take 2.\nEric will deploy will a new version on our internal host so that everyone can review it before the second submission.\nWhen asked if the FDA security work Paul mentioned would lead to a guidance document, Paul replied that it may and noted that there is an internal FDA working group addressing the problem, and that currently Python appears to be a bigger security problem than R.\n(44:26) Paul informed the group that the FDA is being approached by multiple groups, including PhUSE and Transcelerate, about using R and validation issues. The FDA would coordinate the activities of these groups to prevent duplication of effort and decide who is going to do what. He also suggested that we should broaden our base within the FDA and seek to get John Scott and CBER involved.\nAction JBR will invite someone from the R Validation Working Group to attend our next meeting and meet with Paul to identify a representative from PhUSE to invite.\nThe next meeting of the Submissions Working Group will be on Friday, April 7, 2023 at 9AM PST." + "text": "View Attendee List\n\n\n\n\n\n\n“Christopher Kania - Biogen”\n“Doug Kelkhoff - Genentech”\n“Ning Leng - Genentech”\n“Tadeusz Lewandowski - Roche”\n“Eli Miller - Atorus”\n“Eric Nantz - Lilly”\n“Joseph Rickert - R Consortium”\n“Paul Schuette - FDA”\n“Kevin Snyder - FDA”\n“Mike Stackhouse - Atorus”\n“Ben Staub - GSK”\n“Adrian Waddell - Roche”\n“Nan Xiao - Merck”\n“Jiang Xu - FDA”\n“Renping Zhang - FDA”\n“Yilong Zhang - Merck”\n“Jizu Zhi - FDA”\n\n\n\n\nJoseph Rickert brought the meeting to order at 9:04 and began the video recording. He mentioned that Eli Miller reported although we do have credentials to use the FDA submissions gateway, these have timed out. Reactivating gateway access requires that I send an email to the FDA help desk. Eli recommends that I wait until we are nearly ready to submit before doing this.\nNext, Ning Leng presented the recently up dated slides describing the R Submissions Pilot. Ning will upload this slides to the repo.\n\nThe slides include the working time line for the series of pilot submissions:\n\nPilot1: common analysis (Q4 2021 - hopefully Oct/early Nov)\nPilot2: advanced analysis (Q2 2022)\nPilot3: alternative formatting for package submission (TBD)\n\nTimeline for near term work: * 9/30/2021 complete the draft code and documents along with the internal review by the execution team * 10/1 - 10/15 2021: review by the WG * Late Oct: actual submission after adjudication\nThe two major asks from the execution team: 1. WG members: provide feedback during the review in Oct 2. FDA: Identify potential reviewers\nNext, there was a discussion about the content of the submission package and terminology. (9:48 in the video). This discussion also contains and explanation of the strategy for encoding the R package as a text file to get it through the gateway and how we will handle package dependencies.\nIn our documentation and communication we must be careful to distinguish between the Submission package for the pilot and the R Package containing R code that will be a part of the Submission package. Ning and the team will come up with names for both of these maybe: Pilot1 Submission for the Pilot1 Submission Package. The format for the Submission package will match the folder structure for the submission portal.\nJoe then noted that we now have two R Consortium GitHub repositories associated with the working group. 1. https://github.com/RConsortium/submissions-wg is the primary repository for the working group. The Kanban board project on this repo is what we use to manage the submissions project. 2. The repo https://github.com/RConsortium/submissions-pilot1 is the code development repo for the Pilot1 submission.\nNext, Adrian walked through the status of the tasks on the Kanban Board. (20:19 on the video).\nJoe will write a blog post to describing what the submission team is doing with the intention of getting more pharma companies before the submission. Mike Stackhouse will help with getting it through the PHUSE marketing channels.\nThere was a discussion (43:30) about finding an FDA reviewer for the pilot. Paul Schuette took the action item to find someone who will probably be a statistician but not a formally designated FDA reviewer. It was suggested that the criteria for reviewing the pilot submission and the criteria for the success of the project be included in the cover letter.\nJoe asked what would be required to communicate the success of the pilot. Paul stated that formal approval from the FDA would be required for a press release and that the project should be included as part of the FDA’s Technology Modernization Action Plan (T-MAP) and the Data Modernization Action Plan (D-MAP). It would be best to investigate this after we have the proof of concept of the Pilot1.\nIn response to the question if eventually we would want to have the pilot reviewed by a formal FDA reviewer, Paul noted that they have several R competent FDA reviewers especially among the new graduates. However, if a reviewer need help they would most likely reach out to the Paul’s group.\nWhen asked whether would expect reviewers to compare SAS and R results, Paul suggested that we should focus on a limited definition of validation for our first submission.\nWhen asked whether we should have a future goal of having FDA reviewers to take the code in the submission package and and do further analyses, Paul stated that they can do that now. More interesting would be to have the submission package include a Shiny application for interactive data visualization.\nAt the top of the hour Joe asked whether anyone on the call was involved with preparing a presentation about the Submissions project for the upcoming R / Pharma conference. Paul responded that he may be. The FDA is still working out the details of a keynote talk in which Paul will participate. The group extended an offer to help provide material.\nThe group agreed to extend the meeting beyond the hour to review Ning’s proposal for language to be added to section 4.1.2.10 of the Study Data Technical Performance Guide. (1:03 on video) Ning suggested adding:\n\nSubmission of programs with their native file extensions are acceptable, as long as binary file formats and pre-compilde code are not delivered.\n\nPaul stated that .bat files need to be excluded. This launched a discussion of how to generalize this. Paul suggested executable but Doug noted that .bat files are executable on Windows but not on other operating systems. Doug took the action to consider how to describe the issue in a more general fashion. Paul expressed the essential idea as “We can open it, we can look at it, but we don’t want it to run.”\nIn the final minutes, Adrian asked about not having to submit .txt files. Paul suggested that this would require changes within the Agency, and would probably require getting the suggested changes to 4.1.2.10 passed.\nThe next meeting is scheduled for Friday, October 1, 2020. At that meeting we will decide whether we need a special session to provide material for Paul’s presentation.\nThe zoom video recording is available. Passcode: #Sk!6tXL" }, { - "objectID": "minutes/2022-08-05/index.html", - "href": "minutes/2022-08-05/index.html", - "title": "Minutes 2022-08-05", + "objectID": "minutes/2023-01-13/index.html", + "href": "minutes/2023-01-13/index.html", + "title": "Minutes 2023-01-13", "section": "", - "text": "View Attendee List\n\n\n\n\n\n\nDadong Zhang (Illumina)\nEric Nantz (Eli Lilly)\nGabriel Becker (Roche/Genentech)\nHenry Wang (Roche/Genentech)\nJoseph Rickert (R Consortium)\nNing Leng (Roche/Genentech)\nPaul Schuette (FDA)\nRenping Zhang (Johnson & Johnson)\nRobert Devine (Johnson & Johnson)\nSaghir Bashir (Argenx)\nSean Healey (Pfizer)\nXin Qiu (Johnson & Johnson)\nYilong Zhang (Meta)\n\n\n\n\nThe meeting was recorded and the video with passcode: wW@9+Lbx\nNL asked if the R Consortium could establish an RStudio connect server to host the Pilot 2 Shiny submission App which is currently deployed on a Genentech server (https://genentech.shinyapps.io/FDA-app/).\nAction Item: JR will contact RStudio to see what it would take to set up the server.\nNL and EN reported that the Pilot 2 team is in the final stages of preparation. The team recently set up Pilot 2 on the golem framework. teal has been fully incorporated, and the team is in the finals stages of completing the documentation preparing the submission. NL estimates that a submission in mid August is possible.\nAction Item: JR will connect with James Black to determine how Roche wants to announce the open sourcing of teal.\nJR asked for updates from the efforts to make pilot submissions to the authorities in Japan and China. Based on conversations with her Roche colleagues, NL reported that there have be no new developments. The Japanese agency doubts that they have the resources to evaluate a pilot submission. The Chinese authority still appears to be interested in an industry collaboration. Roche China is attempting to form a working group, Ning offered to put anyone interested in touch with here Chinese colleague leading this effort.\nJR asked: under the assumption that Pilot 2 goes really well, does the WG have any concrete suggestions for advancing the use of Shiny in submissions. EN noted that just getting Shiny in the process is a big step.\nThere was some discussion about the target audience for the Pilot 2 submission, and how the Shiny app might appeal to a larger FDA audience than the statisticians who would review a submission.\nThere was a questions about whether FDA reviewers would want to reproduce the Shiny app interactivity. PS noted that FDA reviewers are not Shiny app developers and it is unlikely that the FDA would want to go down that path. GB asked for clarity on the term “independent reproducibility”. PS noted that running the sponsors code in the same environment used by the sponsor is not considered to be independent verification.\nNL asked about specific use cases that may be of interest to the FDA. PS noted that standing up a Shiny app in a real product submission workflow would be more complicated than one might expect because it would have to be integrated into an FDA contractor’s workflow. Using the current infrastructure, it is best to think of a Shiny app being run on an individual’s computer.\nThe discussion turned to the use of containers for submissions. JR asked PS whether about the FDA landscape for containers. PS replied that currently podman has been approved by NCTR, and that if we would like to use that he would have to get approval for CDAR use. Docker is not viable in the short term because of the subscription model, which would require coordination among multiple offices.\nER noted that in addition to podman and Docker he had identified singularity as a possible candidate container technology, but that this product is not as accessible to developers. In his organization, singularity requires an IT administrator to setup. PS noted that if this working group would identify a preferred container technology, he could begin promoting our choice within the FDA.\nYZ asked if we should think about writing up the Pilot 1 and Pilot 2 experience for a journal publication, perhaps a two page letter. The group liked the idea and suggested R journal, ASA Journals, Significance, Chance, DIA Journals, JSS, JAMA and a clinical trials journal were suggested as possibilities.\nNL asked about the possibility of presenting to FDA statisticians. PS said that he would have to consult with FDA management.\nPS suggested something like the recent R Adoption Series Webinar which drew 600 people from industry would be viable. He would invite members of the internal FDA Statistics Association to attend. He suggested a discussion / capstone effort: “Working through the R Consortium industry and the FDA have collaborated with industry in an appropriate way and gone through a step by step process that has involved the FDA at each step.\nAction Item JR and NL to arrange this webinar.\nNext the grouped discussed whether it would be worthwhile to do an additional pilot that would include data generation. The idea would be to start with CDISC SDTM data and derive the data for analysis such as change from baseline etc. PS said that this would be interesting, but that most reviewers start with the analysis data steps. More motivated reviewers will trace key variables to show that they can be independently reproduced. No decision was reached on this matter.\nPS suggested that the WG consider participating in the CDISC TFL Designer Virtual Workshop which will be held on 13 September 2022, 11am - 2pm Eastern Time. Register Here.\nAction Item The group will try to find someone from CDISC who may involved and also search for someone from the working group who might want to attend. JR will write to James Black to see if he has any knowledge of the event.\nThe next meeting of the working group will be at 9AM Pacific Time on Friday, September 2, 2022." + "text": "View Attendee List\n\n\n\n\n\n\nAndrew Borgman (Bristol Myers Squibb)\nBen Straub (GSK)\nBob Engle (Biogen)\nDoug Kelkhoff (Roche/Genentech)\nEric Nantz (Eli Lilly)\nHyeSoo Cho (FDA)\nJizu Zhi (FDA)\nJoel Laxamana (Roche/Genentech)\nKevin Kunzmann (Boehringer Ingelheim)\nLuke Schantz (R Consortium)\nPaul Schuette (FDA)\nPhil Bowsher (Posit)\nRyan Johnson (Posit)\nSean Healey (Pfizer)\nStephanie Lussier (Moderna)\nSteven Hasendinckx (Johnson & Johnson)\nTadeusz Lewandowski (Roche/Genentech)\n\n\n\n\n\n\nPilot 2 Update\n\nPaul Schuette confirms he was able to successfully run the Shiny application\nThey encountered a few messages that they ignored, as the app still ran successfully\nHyeSoo Cho followed the ADRG instructions and launched Shiny app, without major issues\nShe noticed minor issues around errors and warning messages. As part of her evaluation she tried launching the app in different machines to compare results. She saw some inconsistency between the environments, and they will report specific findings by next month (February)\n\n\n\nPilot 3 Update\n\nProposal was sent in early December for comments and feedback https://github.com/RConsortium/submissions-pilot3-adam/issues/37\nRunning into minor issues with using the same specifications and define settings as the original Pilot 1\nThey are not clear on the most up-to-date specifications to use for the AdAM creation, would like help from others\nThomas found a Phuse 2017 white paper on transport files for the next generation. This paper proposed new ways to convert the data before transfer\nAdditional ideas such as a proposal to use JSON format https://wiki.cdisc.org/display/ODM2/Dataset-JSON\nFDA is aware of the proposal, but it is not clear how far the proposal has gone\nStudy Data Technical Conformance Guide details the latest specs and what is acceptable in the gateway https://www.fda.gov/media/162867/download\nSponsors can use SAS version 8 of XPT if they choose, most sponsors are using version 5 from their experience\nOther pilots have explored alternative formats, but have not been satisfactory in their opinion\nIt is common to convert the XPT format to a more consumable format. For instance as sas7bdat in SAS or R objects inside R.\nPilot 3 will adhere to the current specifications\nBen recommended consulting with Sam Hume as a collaborate to push the effort along\nThe ectd gateway would need updating to accommodate json formats. That would require discussions with the E-data team in the FDA\n\n\n\nR Validation Hub intro to Repositories working group\n\nDoug Kelkhoff and Kevin Kunzmann led a an introduction to the mission and goals of the working group\nMission is to support a transparent cross-industry approach of maintaining a repo of R packages with evidence of their quality and assessment criteria\nRepo structure may resemble pieces of CRAN, R Universe . Still in the early stages of finding what is needed before working on the technical solutions\nAsks for regulatory input: Work with the team to understand how you want to observe quality. Paul mentioned that bigger issues that FDA are thinking about are from the IT perspective (making sure that packages don’t compromise infrastructure). Example of haven running into buffer overflow issues. Typically those concerns are raised by security team colleagues. They are not aware of any independent effort to gauge the quality of an R package. Typically they point people to the R Validation Hub. While it is not doing independent replication of algorithms, it is a reasonable attempt in the right direction. Typically all pieces of software give you the “as-is” message and no implied guarantee of quality\nAsks for industry input: Contribute by direct support, or by intermittent feedback as they prepare deliverables\nHigh level of planned deliverables: List of quality criteria, mockup of the communication portal, and an example of a package server modelling a real-world workflow\nVisit the repository to get involved https://github.com/pharmaR/regulatory-r-repo-wg\nBen asked about ways to consolidation various validation efforts heard from other sponsors. What existing tools are being implemented in this space?\nDoug shared an article from the ASA Biopharmaceutical Report regarding the risk assessment of R packages: https://www.pharmar.org/blog/2022/12/05/2022-12-05-asa-biopharmaceutical-report-fall-2022/" }, { - "objectID": "minutes/2022-10-07/index.html", - "href": "minutes/2022-10-07/index.html", - "title": "Minutes 2022-10-07", + "objectID": "minutes/2021-12-03/index.html", + "href": "minutes/2021-12-03/index.html", + "title": "Minutes 2021-12-03", "section": "", - "text": "View Attendee List\n\n\n\n\n\n\nEllis Hughes (GSK)\nEric Nantz (Eli Lilly)\nHonghong Zhou (Moderna)\nJizu Zhi (FDA)\nJoseph Rickert (R Consortium)\nLei Zhao (Roche/Genentech)\nMiriam Fossati (Merck)\nNan Xiao (Merck)\nNing Leng (Roche/Genentech)\nPhil Bowsher (Posit)\nQin Li\nRenping Zhang (Johnson & Johnson)\nRobert Devine (Johnson & Johnson)\nRyan Johnson (Posit)\nSaghir Bashir (Argenx)\nSam Parmar (Pfizer)\nSean Healey (Pfizer)\nTadeusz Lewandowski (Roche/Genentech)\nThomas Neitmann (Roche/Genentech)\nYilong Zhang (Meta)\nThe meeting was recorded and the video is available." + "text": "View Attendee List\n\n\n\n\n\n\n“Phil Bowsher - RStudio”\n“Hye Soo Cho - FDA”\n“Heidi Curinckx - Johnson & Johnson”\n“Miriam Fossati - Merck”\n“Ellis Hughes - GSK”\n“Maria Matilde Kam - FDA”\n“Emily Nguyen - FDA”\n“Jiang Xu - FDA”\n“Steven Hassendinckx”\n“Ning Leng - Genentech”\n“Joseph Rickert - R Consortium”\n“Paul Schuette - FDA”\n“Adrian Waddell - Roche”\n“Nan Xiao - Merck”\n“Hong Yaan - Regeneron”\n“Renping Zhang - FDA”\n“Yilong Zhang - Merck”\n“Jizu Zhi - FDA”\n\n\n\n\nThe meeting was recorded and the video is available here Passcode: 0tA$D+ev\nJR Opened the meeting with the agenda to discuss the recent pilot submission through the FDA gateway and then discuss a request to have interested companies describe what they are currently doing with respect to FDA submissions in R.\nYZ reported that the submission went through the gateway, thanked all who participated and was looking forward to receiving feedback from the FDA.\nJR reported that there were still issues with employees from different companies using the RC portal. The current solution is to have people accessing the gateway on behalf of the RC use an R Consortium email address. JR wants to make sure that this is fine with the FDA.\nAt 6:37 into the video PS begins providing FDA feedback on the submission.\nThe initial findings were:\n\nThe submission was partially successful\nThe were no problems with the .R extensions\nThe FDA was unable to find the Pilot1wrappers package. However, the * * FDA analyst was able to generate tables\nThe FDA thinks there may have been a switch in the high bit vs. bit settings and asked the WG to check this.\nThe FDA analyst was able to retrieve the pilot1wrappers package from the Submission WG website, download the code and verify the results\nThe FDA noted that including a dependency chart showing the 2nd and 3rd order dependencies would be very helpful. If this were and actual submission, at least one IR request would have been generated.\n\nOn behalf of the WG, JR thanked the FDA team for making extra effort to retrieve the wrapper package and run the code.\nIn the subsequent discussion it was determined that the FDA analysts overlooked the instructions, buried in the ADRG, to unpack the pilot1wrappers from the file r0plg.txt. Once this was clarified HC, the FDA analyst, was able to execute the command and unpack the pilot1wrappers package. HY noted that in her experience, submissions with R code tend to be ad hoc, and that it is common to include a README file. The WG took note and agreed that it would be a good idea to include a README file that highlights the key steps, maybe by referring to the ADRG.\nNext, followed a discussion about the requested dependency chart tree diagram. PS noted that the importance of dependencies depends on the setting. When running from a standard machine, FDA analysts are able to pull packages from the internet. However, when running from one of their scientific enclaves high performance computing environments they must port in the packages. To illustrate the problem with dependencies HC showed the error messages generated by calling R packages previously installed on her machine, but which did not have the dependencies installed that are required to run the submission code.\nThe problem seems to be that every file in the submission needs the library calls. This problem needs to be addressed.\nHC also identified a problem of not having write permissions.\nThe temporary solution seems to be to copy the file into a temporary folder. This problem needs more thought.\nIt was agreed that the WG should produce a document about establishing the proper environment. AW suggests that there are two possible actions: 1. Copying to a local folder might clear up most of the problems 2. If not, the WG should look into environment reproducibility\nPS noted that the FDA does not need to run on a central server. This implies that we can assume FDA analysts running on their local environments for the near future.\nPS suggested having a pre-submission meeting explaining everything that is necessary to get everything installed and working.\nAW suggested that we set up the submission assuming that each file will be run from a fresh R session, and that perhaps we could run some tests to see if the environment is as is expected.\nNL asked about writing a blog post about the pilot submission. The WG agreed to write up the post and have PS and HC review.\nYL asked about redoing the submission. PS said indicated that is common practice.\nNL said that she and HC would like to schedule a separate meeting early next year to discuss where the various participating companies are in the process of making R submissions. Please let NL know if you are interested in participating.\nThe next meeting is set for 9:00 AM Pacific Time on Friday, January 7, 2022." }, { - "objectID": "minutes/2022-10-07/index.html#da-japan-talk", - "href": "minutes/2022-10-07/index.html#da-japan-talk", - "title": "Minutes 2022-10-07", - "section": "DA Japan Talk", - "text": "DA Japan Talk\n(31:30 min into video) Tadeusz presented a Shiny application that he developed for a presentation he is going to make at the DIA Japan conference on October 9, 2022. The intention of the presentation is to gauge the interest of the Japanese authorities. The session in which Tadeusz will present is called LS09 Innovative and Dynamic Statistical Analytics for Regulatory Submissions" + "objectID": "minutes/2021-05-07/index.html", + "href": "minutes/2021-05-07/index.html", + "title": "Minutes 2021-05-07", + "section": "", + "text": "View Attendee List\n\n\n\n\n\n\n“Bryant Chen - FDA”\n“Bob Engle”\n“Steven Hasendinckx J&J”\n“Doug Kelkhoff - Genentech”\n“Ning Leng - Genentech”\n“Eric Nantz - Lilly”\n“Joseph Rickert - R Consortium”\n“Paul Schuette - FDA”\n“Mike Stackhouse - Atorus Research”\n“Adrian Waddell - Roche”\n“Nan Xiao - Merck”\n“Yilong Zhang - Merck”\n\n\n\n\n\nRecording\nThe meeting was recorded and the video is available at the link given below. Time stamps in the Minutes refer to the video.\n\n\nMinutes\nJoseph Rickert opened the meeting at 9AM Pacific Time and told the group that Mike Stackhouse has revised the document for a pilot submission which is in the document folder of the GitHub repo. He asked Mike to give an overview.\n1:10 Mike’s Overview: The Submissions Working Group should make the opportunity to test out the pkglite package and try to get a pilot submission through the eCTD gateway. The objective would be to determine if an FDA reviewer would be able to receive and consume the content. This effort would be a discovery process exposing unanticipated problems in getting an R submission through the gateway and help to identify difficulties an FDA consumer would have in replicating the outputs of the pilot.\nMike stated that having a concrete example of pushing an R submission through the gateway would be “momentous”.\n6:37 Joe asks Paul Schuette if he agrees with Mike’s assessment of the benefits of the pilot. Paul affirms that it would be helpful and suggest using a simulated data set.\n7:55 Joe asks Paul if special preparation would have to happen on the receiving side. Paul replies that it would depend on the processes and procedures of gateway, and notes that in the past the authorities have asked for submissions by DVD and mail (This came up last year with respect to submitting University COVID tests.)\n11:03 Paul recommends putting in a formal request to involve additional agency reviewers. Mike suggests that submitting through Phuse would have some advantages since Phuse has a structured relationship with the FDA.\n12:53 Based on previous experience, Paul states that his is not certain about the efficacy of the Phuse relationship, but that he does not have serious objections\n15:06 Paul raises the possibility that the R Consortium could sponsor the pilot. Doug Kelkhoff, Yilong Zhang and others endorse this idea.\nAdrian Waddell asks how difficult is it to make a submission? Paul replies that he is not sure, but adds that to his knowledge at least one foundation has made a submission in the past. He advises we would have to reach out to group that manages gateway and EDR, and remarks that the R Consortium may have resource issues that pharma company does not have.\n17:37 Adrian alternative:\n\nSplit out the data and analysis code which need to be secure and go through gateway process.\nPut the code that does not involve patient level data on a public Github repository and devise a secure way to give the agency access.\n\n19:35 Paul describes a similar process he and Eric went through with a Lilly pilot where Paul had access to a Lilly Github site for 8 hours. This was a process that agency was able to handle with Eric’s help, but it was a one-off effort as part of CID pilot and not a typical submission. He speculates that the process would probably not be allowed as part of standard submission package.\n26:09 Mike brings the conversation back to logistics of getting a submission number to get the pilot process started.\n27:24 Joe asks if it is possible for more than one company to make joint submission and Doug clarifies this to mean have multiple companies co-sponsor a submission. He that the word “Sponsor” has a technical meaning to the FDA and that the system is set up for sponsors to be a company. The group agrees that the ideal would be to have R Consortium be the surrogate sponsor of the pilot.\n28:48 Paul suggests that we assess the possibility of having the R Consortium sponsor by reaching out to Ethan Chen who heads up the Division of Data Management Services and Solutions. Doug suggests that we invite Ethan, or someone designated by him to our next meeting.\nPaul notes that the invitation should be a formal process and suggests that as the representative of the R Consortium Joe write to Ethan to ask his group to participate in the process of planning for a pilot submission. Paul suggests that the letter could reference him and that the content of the letter emphasize that our group is part of an industry effort to help enhance and modernize submission tools. We are independent of, but in line with the recent Transcelerate MSA framework and the work being done by the R Validation Hub. Both of these efforts provide some justification as to why companies and consortia are interested the submissions process.\n34:37 Joe agrees write the email letter. Doug, Eric and other agree to help with drafting it.\n40:40 a discussion about whether approvals need to be obtained from the individual pharmaceutical companies\nAdrian points out that we would want to be able to try multiple approaches, and Paul indicates that an advantage of having the R Consortium sponsor would be to have multiple updates on the same submission number. It can sometimes take some companies multiple efforts to get something through the gateway\n46:53 Adrian asks when we make a solution how does the analysis code access the data? Paul replies that the standard is to have an M5 folder to hold CDISC tabular data and analysis data - code can be in separate folder or along with analysis data sets.\n51:00 Adrian describes the main goal to give health authorities something that they can easily use themselves.\n51:30 states the measure of success : Deliver something like like the CDISC package through eTCD and have and FDA reviewer recreate and install packages and reproduce the results\n54:41 Doug advises that the letter be general with no technical detail stating the R Consortium’s interest in being a sponsor and asking for agency participation.\nAction item Joe to draft letter and place it in the documents folder of the submissions repo by Tuesday of next week. The team will review and comment.\nThe video recording of the meeting is available here Passcode: Gb#E@4$S" }, { - "objectID": "minutes/2022-10-07/index.html#subgroups", - "href": "minutes/2022-10-07/index.html#subgroups", - "title": "Minutes 2022-10-07", - "section": "Subgroups", - "text": "Subgroups\nThe working group discussed writing writing some material for the GitHub repository explaining the purpose of the various subgroups, listing the members, and explaining how newcomers can get involved.\nAction Item Joe and Eric will meet after the Pilot 2 submission to discuss documenting the subgroups." + "objectID": "minutes/2022-01-07/index.html", + "href": "minutes/2022-01-07/index.html", + "title": "Minutes 2022-01-07", + "section": "", + "text": "View Attendee List\n\n\n\n\n\n\n“Phil Bowsher - RStudio”\n“Heidi Curinckx - Johnson & Johnson”\n“Graeme Hickey - BD”\n“Ellis Hughes - GSK”\n“Emily Nguyen - FDA”\n“Jiang Xu - FDA”\n“Steven Hassendinckx”\n“Ning Leng - Genentech”\n“Joseph Rickert - R Consortium”\n“Paul Schuette - FDA”\n“Nan Xiao - Merck”\n“Renping Zhang - FDA”\n“Yilong Zhang - Merck”\n“Tadeusz Lewandowski - Roche”\n“Michael Mayer - RStudio”\n“Eric Nantz - Lilly”\n“Xin Qiu”\n“CG Wang”\n\n\n\n\nThe meeting was recorded and the video is available with Passcode: g?xb.9fs\nNing Leng began the meeting by providing a brief summary of recent submission. We received written feedback from the FDA which is available in the submissions repository here. There were a few findings with the pilot:\n\nA mislableed treatment arm (This is a potential bug)\nA rounding issue\nTable fomatting\n\nNL noted that our execution team was not able to recreate the rounding issue, and asked PS is it would be possible to for us to look at the FDA code. This is possible, but needs to be cleared with management and may take a couple of weeks,\nNing and the other members of the submission execution team are looking into these and hope to be able to submit a follow up to Pilot 1 in several weeks. Ning asked if the FDA would be willing to review the resubmission of Pilot 1. PS said that this would be fine.\nThe discussion then moved to the contents of Pilot 2. PS noted that with submitting .R files we already met some of the goals we had been planning for Pilot 2.\nTo begin the discussion JR asked: what kinds of things have been considered difficult to do in submissions in the past and what could we do that would be impressive from the FDA’s point of view?\nPS suggested package versioning and archival issues\nNL suggested four topics that have come up in previous discussions.\n\nPackage versioning\nUsing Docker\nAlternative data formats to sas7bdat\nShiny\n\nEN agreed that these were the top issues, and noted that using a container such as Docker would also solve the package versioning.\nPS remarked that doing anything with data formatting is unlikely at this time. Two recent pilots failed to come up with an alternative. This is “not the hill to die on” right now. It is probably an issue that is worthy of broader discussion with other groups such as ASA, DIA, or PHUSE. PS suggested looping in Heather Crandall and OBI, the Office of Business Informatics.\nPS also noted that Docker has made changes to licensing so that FDA is not able to play with local installations of Docker. EN said that he was aware of these issues and suggested alternatives such as podman which he believes to be the first candidate to investigate. PS stated that any container technology would have to be approved by IT. He also noted that the FDA is currently using an obsolete version of Docker, and that upgrading to a newer version would have to go through the FDA approval process. Also, the FDA security team will not let containers have access to the hard drive. The group concurred that since getting Docker approved would not be any easier than podman the group should explore this new technology. EN offered to take the lead on this and enter the task into the Kanban board.\nPS suggested that since we have just shown that we can get a package through the gateway, the next step might be to turn a shiny app into a package and pass it through the gateway. EN confirmed that this is indeed possible and noted that the golem package can do this and deploy the shiny app locally without having to go to a server.\nYZ noted that he has seen several linkedin posts about using Shiny for submissions and asked if that was happening in this group. PB stated that this Shiny submissions effort is being run by the R/Pharma group. They are planning to start holding monthly meeting, the first being at the end of January. R/Pharma wants to focus on the technical issues.\nThe group agreed that the path forward with Shiny as a package is much more straightforward than using containers, and suggested that we settle on Shiny for Pilot 2 and Containers for Pilot 3.\nThe discussion then turned on which Shiny app we should select. TD suggested the teal package that Roche is working on and noted that Roche is planning to make this open source. The group agreed that the source code of any Shiny package submitted should be open source.\nAt 30:03 into the video, TL demonstrated the teal package. After the demo, the group discussed the benefits of submitting a complicated package like teal which has several interesting features versus a simple app that meets the basic requirements. PS noted that ideally we would want to launch server from a local PC and not touch a server. To do otherwise would require the FDA to involve a special contractor and funding. The group decided to use a simple app and NL suggested wrapping the Pilot 1 modules into a Shiny app.\nAt 46:15 into the video, TL demonstrates calling different packages from a Shiny app.\nEN agreed to open up a second repo for development of Pilot 2. We will keep use the same setup as Pilot 1 and have the kanban board on the main submissions repo point to the Pilot 2 repo.\nJR said that he would follow up with PHUSE about work they may be doing on the formatting issue.\nNL asked about accumulus synergy, an FDA and cross industry looking at cloud solutions. Would there be a way to connect our container effort with accumulus? The group suggested searching for a contact.\nJR noted that before the next submission of Pilot 1 we must write to the FDA to reopen the gateway.\nThe next meeting of the working group will be at 9AM Pacific Time Friday, February 4, 2022." }, { - "objectID": "minutes/2022-10-07/index.html#containers", - "href": "minutes/2022-10-07/index.html#containers", - "title": "Minutes 2022-10-07", - "section": "Containers", - "text": "Containers\nThe working group agreed that the planned project to submit a containerized version of the Pilot 2 submission will require a significant amount of new work and pose several challenges. It should therefore be new, independent pilot submission, perhaps Pilot 4-Containers." + "objectID": "minutes/2022-11-04/index.html", + "href": "minutes/2022-11-04/index.html", + "title": "Minutes 2022-11-04", + "section": "", + "text": "View Attendee List\n\n\n\n\n\n\nBob Engle (Biogen)\nEllis Hughes (GSK)\nEric Nantz (Eli Lilly)\nGregory Chen (MSD)\nHeng Wang (Roche/Genentech)\nHonghong Zhou (Moderna)\nHyeSoo Cho (FDA)\nJizu Zhi (FDA)\nJoel Laxamana (Roche/Genentech)\nJoseph Rickert (R Consortium)\nLei Zhao (Roche/Genentech)\nNan Xiao (Merck)\nNing Leng (Roche/Genentech)\nPaul Schuette (FDA)\nRenping Zhang (Johnson & Johnson)\nRobert Devine (Johnson & Johnson)\nSaghir Bashir (Argenx)\nStephanie Lussier (Moderna)\nTadeusz Lewandowski (Roche/Genentech)\nYilong Zhang (Meta)\nYiwen Luo (Merck)\nYutong Liu (Moderna)\n\n\n\n\n\nThe video is available on the R Consortium YouTube Channel\nThe meeting began with EN summarizing his understanding of the comments made by PS about his preliminary look at the Pilot 2 submission package.\nThe following is a summary of Paul’s comments which were made in a email exchange with the workgroup members on 10-27-22:\n\nPaul has management approval to proceed with Phase 2 of the pilot, with the proviso that the Demographic, Primary and Efficacy Tables are static.\nThere is a minor error in the app: the low dose and high dose column settings reversed.\nThe efficacy table is slightly misleading as it currently stands. Suggest that the text for the first row read “Study Drug (High Dose)” or similar.\nSuggest an additional table: “Subjects Remaining in the Study” showing how dropouts proceed. (See Paul’s email of 10-27-22 for details) This might show how exploratory analysis might add value over the prespecified\nThe number of decimal places displayed in the demographic table isn’t always the same as in pilot 1.\nSuggest that the model specification information be included with the efficacy table rather than left to the app information.\n\nWe would like the app to be able to serve as a model for future submissions.\n\nEric stated that the updates appear to be relatively minor and would not be difficult to accomplish.\nThe submission team agreed to target 11-18-2022 as the target submission date.\nAction: JBR to put a 9AM 11-18-2022 on the calendar for the submission.\nJBR asked Paul to describe the boundary between a useful amount and too much interactivity in a shiny submissions app. Paul replied that it a way to think about it would be the difference between exploratory and inferential analysis. The problem with inferential analysis is the usual problem with p-values, subgroups and cherry picking. Inferential analysis is not the way to go. A Kaplan-Meier curve would be considered an exploratory safety analysis.\nWhen asked if the guidance on interactivity was likely to stand for some time or change with familiarity Paul replied that it was his personal opinion that since it is consistent with the ASA Statement on p-values it will probably stand.\nPaul also remarked that interactivity facilitating pre-specified analyses would probably be fine.\nThe following links may be helpful with understanding potential problems with on subgroup analyses:\n\nAlosh et al. (2015)\nAlosh et al. (2016)\n\nJoel Laxamana gave an update on the Pilot 3 effort:\n\nThe kickoff meeting for the team was held this past Wednesday\nThere are 13 people on the team\nThe goal of Pilot 3 is to duplicate Pilot 1 but also generate the ADaM data sets used for the TLGs in Pilot 1\nThe idea is to start with the STDM and show the traceability to ADaM\nPilot 3 will use the admiral package along with tidyverse packages.\n\nAction: Joel will add this explanatory material to the Pilot 3 GitHub repo.\nAction: Joel will send a list of Pilot 3 team members to be added to the invitation list for this meeting.\nAction: The Pilot 3 team will submit a written proposal to the FDA describing the process of unpacking the submission and setting up for analysis. The target date is to have this proposal ready for the 12-02-2022 Submissions WG meeting.\nLei Zhao asked if it would be a problem submitting data in SAS in doing the analysis in R. In general there is no problem, however the FDA suggests using a limited number of tools and using standard tools to do any translations between formats. The FDA prefers using scripted languages as opposed to using a GUI.\nNing will be presented at the R/Pharma conference on Wednesday, November 9, 2022 at 11AM Eastern Time. The next meeting of the regular meeting of the group will be at 9AM Pacific Time on Friday, December 2, 2022." }, { - "objectID": "minutes/2024-02-02/index.html", - "href": "minutes/2024-02-02/index.html", - "title": "Minutes 2024-02-02", + "objectID": "minutes/2022-02-04/index.html", + "href": "minutes/2022-02-04/index.html", + "title": "Minutes 2022-02-04", "section": "", - "text": "View Attendee List\n\n\n\n\n\n\nDadong Zhang (Illumina)\nEric Nantz (Eli Lilly)\nEva Li\nGregory Chen (MSD)\nHyeSoo Cho (FDA)\nJizu Zhi (FDA)\nJoel Laxamana (Roche/Genentech)\nJoseph Rickert (R Consortium)\nKaushal Shah (ASU)\nNan Xiao (Merck)\nNing Leng (Roche/Genentech)\nPaul Schuette (FDA)\nRenping Zhang (Johnson & Johnson)\nRobert Devine (Johnson & Johnson)\nSaghir Bashir (Argenx)\nSam Parmar (Pfizer)\nYoun Kyeong Chang (FDA)\nThe meeting was recorded and the video is available." + "text": "View Attendee List\n\n\n\n\n\n\n“Phil Bowsher - RStudio”\n“Heidi Curinckx - Johnson & Johnson”\n“Graeme Hickey - BD”\n“Ellis Hughes - GSK”\n“Emily Nguyen - FDA”\n“Jiang Xu - FDA”\n“Steven Hassendinckx”\n“Ning Leng - Genentech”\n“Joseph Rickert - R Consortium”\n“Paul Schuette - FDA”\n“Nan Xiao - Merck”\n“Renping Zhang - FDA”\n“Yilong Zhang - Merck”\n“Tadeusz Lewandowski - Roche”\n“Michael Mayer - RStudio”\n“Eric Nantz - Lilly”\n“Xin Qiu - Johnson & Johnson”\n“CG Wang”\n“Michael Blanks - Beigene”\n“Gregory Chem - MSD”\n“Hey Soo Choo - FDA”\n“Bob Engle - Biogen”\n“Bella Feng - EQRx”\n“Miram Fossati - Merck”\n“Ryan Johnson - RStudio”\n“Christopher Kania - Biogen”\n“Shannon Lewis - Beigene”\n“Eli Miller - Atorus”\n“Jonathan Tisack - Beigene”\n“Shiva Kalyan Voruganti”\n“Hong Yan - Regeneron”\n“Patruchi”\n\n\n\n\nThe meeting was recorded and the video (Passcode: &nET4J?I) is available.\nJR began the meeting and asked NL to give an overview of the GitHub repositories for the Submissions WG. Every submission will have two repositories: a development repo and a repo that follows the FDA ECTD structure that contains the files that will go through the gateway.\n\nsubmissions-wg is he umbrella repo that contains the kanban board for the project.\nsubmissions-pilot1 is the development repository for the Pilot 1 submission\nsubmission-pilot1-to-fda contains the only the files that will go to the FDA\nsubmissions-pilot2 is the development repo for Pilot 2\n[https://github.com/RConsortium/submissions-pilot2]\n\nThe group then summarized the present status of the project. The Pilot 1 submission of last year was mostly successful but the FDA response flagged a couple of problem areas: * An apparent but the resulted in column labels being switched * An unexplained rounding discrepancy in a p-value may be due to different operating systems. * Several good practice issues to address\nHSC who helped to conduct the FDA review of the Pilot 1 submission offered to share the code that flagged the rounding error. She will enter it as an issue on the submissions repo.\nThe Pilot 1 team has been working on the Pilot 1 resubmission. The team will will review the FDA code and test it on multiple operating systems. They expect to be able to resubmit in a couple of weeks. NL asked if HSC could look over the new code before they do so. Assuming that the resubmission goes well the group will prepare a blog for posting on the RC blog.\nNL then reviewed plans of the Pilot 2 shiny submission. It is envisioned as a simple four tab Shiny app that contains the same analyses as the previous submission. The plan is to use the Roche teal framework because of its filtering structure.\nYZ then outlined work required to complete the Pilot 2 work and identified three dependencies:\n\nteal must become open source\nThe scope of Pilot 2 needs to be clarified\nA template needs to be developed for submission documentation that includes a Shiny app.\n\nYZ recommended that a separate Pilot 2 documentation team be formed to work on the Shiny documentation in parallel with the code development for Pilot 2.\nEN said that he had experience preparing this sort of documentation and agreed to lead the documentation task.\nJR asked when teal would become open source and whether the fact that it is not now open source prohibiting other companies from contributing to the project. TL responded that project to open source teal is currently with the Roche lawyers and that he expects it will be complete within three months. No one present believed that not currently having teal as open source code was prohibiting participation. Everyone will be able to run the Shiny app from a public website. EN noted that work on infrastructure can proceed in parallel.\nThe team working on Pilot 2 said that a submission in Q2 is feasible.\nCurrently there are not plans for multiple Pilot 2 submissions. However, it is likely that we would want to have a submission in the future that includes a more complicated Shiny app. JR noted that it would be optimal if the FDA could provide guidance on what features they would like to see in a more robust Shiny app.\nMoving beyond Shiny JR asked if by the end of the year we would be looking a submission based on container technology. EN remarked that that is the direction the group would like to see but since Docker is not suitable (because of licensing issues) it will be necessary to research alternative container technology.\nJR noted that having 29 people in the meeting indicated that there was considerable industry interest in the work being done and whether it would be possible to recruit a team to do the research for long range projects. He asked group members who are not involved in immediate work to get involved in long term planning. EN noted that we definitely need to help from the regulatory side to help effect any changes that would have to be made to make use of container technology.\nThe discussion then turned to the possibility of making a submission to CDE the Chinese health authority. (See issue #62 ) They are trying their own submissions gateway. They have shared validation software with Roche that could check a submission. NL suggested that we undertake an effort to see if we could validate a test submission using the Chinese supplied software. If that worked the only additional work to be done to make a viable submission to the CDE would be to translate the documentation into Chinese.\nNL asked if anyone has contacts with the CDE that could review a test submission from the Submissions WG. JR asked EN if she could check with PS about possible FDA contacts with the CDE.\nBF noted that her company, EQRx, has the opposite problem. They have had a compound approved by the CEA and now want to submit it to the FDA. She noted that there are high level regulations about the transfer of data between China and the FDA. The CDE has an HGR application that must be approved by the Human Genetic Resources Agency for China. HY offered that she has some experience dealing with the CDE, having done two or three submissions to the CED in the past when she worked for Novartis. At that time the CDE accepted the FDA package.\nThe discussion they turned to other countries HY noted that she is working on a submission to the Japanese PMDA which the group aggreed is more strict than the CDE an offered to look for a contact there.\nYL noted that the German authorities have strict requirements about the table formats.\nJR asked if there is there is a European authority that we should have on our radar. Apparently, the EMA does not presently require a data submission, but that may be changing. TL noted that they have had a proof of concept sharing data with the EMA.\nYL also raised the possibility of following the PHUSE ADGR template. He suggested that we contact PHUSE and ask if they would be willing to update the template so that it does not specify SAS data sets. JR agreed to look for a contact within PHUSE. We would want a language agnostic template.\nNL noted that this would be a good time to revisit our effort to develop suggested language for section 14 (issue #38).\nJR suggested that we need some high level planning document to capture all of the ideas presented.\nAt 47:10 in the video NL explains the contents of the Submission WG GI Hub sites.\n\nSome useful links from the chat box\nR Consortium GitHub sites: https://github.com/RConsortium/\nWG web page: https://rconsortium.github.io/submissions-wg/\nTracker for the pilot1 submission: https://github.com/RConsortium/submissions-pilot1-to-fda/issues\nhttps://github.com/RConsortium/submissions-wg/issues/38\nIssue filed for pilot 2 documentation : https://github.com/RConsortium/submissions-wg/issues/63" }, { - "objectID": "minutes/2024-02-02/index.html#pilot-3", - "href": "minutes/2024-02-02/index.html#pilot-3", - "title": "Minutes 2024-02-02", - "section": "Pilot 3", - "text": "Pilot 3\nHye Soo Cho presented a summary of the findings of the from the FDA review\n\nDifferent versions of R and RStudio\n\nThere were issues switching between R versions\nThe FDA would like the wg to explore the impact of different versions of R,RStudio and RTools\nAlso Linux vs. Windows\n\nDifferences between generated Pilot 2 ADaM and CDISC data sets\n\nattributes\ntypes (e.g. integer vs. double)\nNA vs. NULL\n\nPackage and file names\n\nIncorrect package name (pilot3utils)\nFile name change (Pilot 3.xlsx to adam-pilot-3.xlsx)\n\nFile path\n\nThe location of a director was specified using relative file path\nRecommendation: use full path name\n\nDifferent primary output in Pilot 1 and Pilot 3\n\nThere are discrepancies between Pilot 3 ADaM and CDISC datasets\nDiscrepancies are noted in QC findings in ADRG\n\n\nThere was considerable discussion about the challenges of dealing with different R versions and establishing a Windows test environment to test a submission before transmitting it to the FDA.\n\nThe idea of setting up a gold standard windows test environment was considered but reject as beginning impractical. The actual FDA environment changes frequently because of hot fixes addressing security concerns.\nIt appears that the most practical path forward as to what preemptive measures sponsors can take to match submission environments with the FDA test environment is to work with the FDA to lock down the environment as best as can be done just prior to submission.\nAn interesting note: Paul mentioned that the FDA no longer pushes the idea of last observation carried forward for imputations. They favor exploring multiple imputation methods.\n\nActions:\n\nThe FDA will consider the implications of what was discussed today and decide if we are ready to resubmit Pilot 3 by the next meeting in March. The submission will use the .zip approach.\nJoel agreed to speak with Eric about establishing an automated way to set up a container running a “vanilla” Windows test environment. Note: in a series of private email conversations after the meeting Robert Devine volunteered his expertise to work with Eric and Joel to set up the windows environment." + "objectID": "minutes/2024-03-01/index.html", + "href": "minutes/2024-03-01/index.html", + "title": "Minutes 2024-03-01", + "section": "", + "text": "View Attendee List\n\n\n\n\n\n\nEric Nantz (Eli Lilly)\nHeidi Curinckx (Johnson & Johnson)\nHyeSoo Cho (FDA)\nJizu Zhi (FDA)\nJoel Laxamana (Roche/Genentech)\nJoseph Rickert (JBR) (R Consortium)\nLovemore Gakava (Novo Nordisk)\nNan Xiao (Merck)\nNicholas Masel (JRDUS)\nNing Leng (Roche/Genentech)\nPaul Schuette (FDA)\nRobert Devine (Johnson & Johnson)\nSaghir Bashir (Argenx)\nSam Parmar (Pfizer)\nYoun Kyeong Chang (FDA)\n\nThe meeting was recorded and the video is available." }, { - "objectID": "minutes/2024-02-02/index.html#pilot-4", - "href": "minutes/2024-02-02/index.html#pilot-4", - "title": "Minutes 2024-02-02", - "section": "Pilot 4", - "text": "Pilot 4\nEric provided a brief update on Pilot 4.\n\nHe will convene the Pilot 4 team to test the Webassembly submission,\nThe submission should be ready by mid March.\nWe will decide on an actual submission date in March.\nEric will invite the Appsilon engineers who have be providing assistance on the project to one of our meetings as we get closer to the submission.\nThe container version of the Pilot 4 submission will coordinate with the FDA to make arrangements for working with containers." + "objectID": "minutes/2024-03-01/index.html#plot-3-update", + "href": "minutes/2024-03-01/index.html#plot-3-update", + "title": "Minutes 2024-03-01", + "section": "Plot 3 Update", + "text": "Plot 3 Update\n\nFDA Recommendation\nHyeSoo stated that the FDA is considering issuing a recommendation that submissions sponsors should use the most recent patch version of the previous minor version of R.\nFor example, R versions are organized as V x.y.z where:\n\nx is the major version\ny is the minor version or subversion\nz is the patch version\n\nThe WG members affirmed that a policy of using a proven stable version of R and not the latest version is in accordance with the practices of their respective companies.\nAfter some thought the working group proposed that since patch versions are issued frequently (every couple of months), it might be better to have the FDA guidance suggest the last patch version of the previous subversion.\nNote that the FDA is considering making a recommendation and not considering setting policy.\nAction: JBR will confer with Sam, Paul and HyeSoo about the wording of the recommendation and then draft a blog post. The post will go to Paul, HyeSoo, Eric, and Ning for review before being published on the R Consortium Blog." }, { - "objectID": "minutes/2024-02-02/index.html#presentation-to-swiss-medic", - "href": "minutes/2024-02-02/index.html#presentation-to-swiss-medic", - "title": "Minutes 2024-02-02", - "section": "Presentation to Swiss Medic", - "text": "Presentation to Swiss Medic\nOn January 30, Gregory Chen presented the activities of our working group in person to an audience 15 people at the swissmedic regulatory agency and 50 people online. Gregory’s slides are in the github repository. He summarized the discussion that took place after his presentation.\n\nThe swissmedic audience was very interested in the use of Shiny for the Pilot 2 submission and would like to work with the R Consortium to explore the possibility of doing something similar at swissmedic. They discussed two possible ways to proceed:\n\nA Pilot 2 like project\nHaving sponsors set up a cloud environment\n\nThe swissmedic audience said that they would prefer an industry collaborative effort rather than a vendor specific solution.\nThe were interested in learning about the resources the FDA allocated to the Pilot 2 and * asked about creating Shiny applications for market authorization.\nThe WG was excited about the possibility of collaborating with swissmedic\nHowever, after some discussion it was decided that this opportunity should be pursued by a new working group devoted to swissmedic.\nWe should also find out if swissmedic has discussed these ideas with the EMA.\n\nAction:\n\nJBR will work figure out how best to recruit members for a new working group focused on swissmedic.\nThis should include a call to the industry to identify people with European connections who could lead this effort.\n\nThe next meeting of the working group will be at 9AM PST on Friday, March 1, 2024,\n\nAbstract for Gregory’s Presentation\nName of presenter: Gregory Chen\nAffiliation: MSD, Switzerland; R Submission Working group (R Consortium)\nBrief introduction of the working group:\nThe R submission working group is a cross-industry working group in pharma, focusing on improving practices of R-based clinical trial regulatory submissions. Our mission is to make R-based clinical trial regulatory submissions easier today and tomorrow by\n\nshowing open examples of using current submission portals,\ncollecting feedback and influencing future industry and agency decisions on system/process setup\n\nTitle: R and Shiny in regulatory submission\nAbstract:\nIn recent years, statisticians and analysts from both industry and regulatory agencies have increased adoption of open-source software such as R. Compared to other statistical programming languages, R brought great benefit from its vibrant open-source community, providing a wealth of cutting-edge statistical tools and adaptability to the latest data science trends. Particularly, R shiny provided great flexibility and interactivity to increase data scientists productivity and make it easier to extract insights or review through massive statistical outputs. To test the concept that R language and shiny app can be bundled into a submission package and transferred successfully to FDA reviewers, the R Submission Working group (R Consortium) successfully completed two pilot submissions to FDA fully in R, and received CDER response letters (pilot 1, pilot 2). To our knowledge, these are the first publicly available submission packages that include components of open-source languages. In this talk, we will introduce R consortium, particularly its Submission Working group, and the completed pilot 1 and 2." + "objectID": "minutes/2024-03-01/index.html#pilot-3-update", + "href": "minutes/2024-03-01/index.html#pilot-3-update", + "title": "Minutes 2024-03-01", + "section": "Pilot 3 Update", + "text": "Pilot 3 Update\nHyeSoo and Joel informed the group that they met last month to resolve the discrepancy between the original CDISC version of the ADADAS ADaM data set and the Pilot 3 version of the ADaM data set. Joel noted that there are 818 available records in the QS domain. The CDISC ADADAS only brought in 799 records and imputed the rest, whereas Pilot 3 brought in all available 818 records into ADADAS and then imputed. When the Pilot 3 team adjusted by subsetting to ANL01FL=‘Y’ records first before doing the LOCF imputation the results matched Pilot 1 and the discrepancy was resolved. Look here for details.\nThis issue illustrates the level of detail that the FDA must consider in replicating a sponsor’s submission environment. This particular issue was due to a statistical decision and not an error. Ning pointed out that most of the work in resolving discrepancies over the three Pilot submissions are due to insufficient documentation and inadequate communication and not to differences between SAS and R.\nAction: Ning and Joe will work on a blog post about this topic." }, { - "objectID": "minutes/2021-03-05/index.html", - "href": "minutes/2021-03-05/index.html", - "title": "Minutes 2021-03-05", - "section": "", - "text": "View Attendee List\n\n\n\n\n\n\n“Joseph Rickert - R Consortium”\n“Adrian Waddell - Roche”\n“Paul Schuette - FDA”\n“Bella Feng - EQRX”\n“Yilong Zhang - Merck”\n“Doug Kelkhoff - Genentech”\n“Mike Stackhouse - Atorus Research”\n“Nan Xiao - Merck”\n“Ning Leng - Genentech”\n“Steven Hasendinckx J&J”\n“Bryant Chen - FDA”\n“Ojesh Upadhyay - GSK”\n\n\n\n\nJoseph Rickert opened the meeting at 9AM Pacific Time and pointed to the agenda in the Discussion Section of the GitHub repo.\nAgenda: 9:00: Doug Kelkhoff - R Validation Hub infrastructure 9:05: Nan Xiao the R package pkglite which packs/unpacks multiple R packages into txt file is going to be used in an upcoming FDA pilot eCTD submission 9:30: Open discussion We will continue the discussion initiated by Paul Schuette last time about modifying the software section of the study data technical conformance guide\nDoug provided an overview of the R Validation Hub protect, pointed out areas of overlap with this working group and welcomed those interested to participate in the Validation Hub effort. Detailed information on the R Validation Hub project which is also organized as an R Consortium working group can be found here.\nNext, Nan Xiao of Merck gave an overview and demo of the R package pkglite which is expected to be up on CRAN soon.\nThe specific aims of the package are:\n\nAim 1: To provide a tool for packing and restoring R packages as plaintext assets that are easy to store, transfer, and review.\nAim 2: To provide a grammar for specifying the file packing scope that is functional, precise, and extendable.\nAim 3: To provide a standard for exchanging the packed asset that is unambiguous, human-friendly, and machine-readable.\n\nNan’s presentation can be found in the Document’s section of the R Consortium/submissions-wg GitHub repository.\nYilong stated that he hoped that our working group could collaborate on a pilot submission to the FDA. He prepared the following outline to be included in these minutes.\nGoal: prepare a open source dummy submission and submit to eCTD portal\nThe information below is to track potential high level action items. Individual issues can be created to track the progress later.\nData source: CDISC pilot submission\nR program for table listing and figure (TLFs): program\nGeneral action items:\n\nMake sure this use case is following CDISC terms of use\nIdentify TLFs in-scope for submission\n\nAction items for dummy submission package preparation:\n\nIdentify point of contact to initiate dummy submission request\nPrepare analysis results metadata\nPrepare step-by-step instruction to re-run analysis based on code in program folder and put in ADRG: link\nWrap-up submission package\n\nThose present all seemed to be enthusiastic about cooperating on the generating a dummy submission.\nNext, followed a lengthy discussion on the required process. Mike Stackhouse suggested that we work with PHUSE to suggest people who may be knowledgeable about past CDISC submissions. Paul Schuette recommended Zak Skrivanek.\nYilong Zhang mentioned that Merck intends to use this package as part of a pilot oncology submission in the near future. Bella mentioned that the FDA Oncology group had specified SAS.\nNing Leng of mentioned that Roche is preparing a rare disease submission for 2022.\nJoe Rickert asked the group: assuming the pkglite dummy submission is successful, how far the this would advance us towards the ultimate goal of an all R submission.\nWhile everyone was very excited about the pkglite all agreed with Doug Kelkhoff’s sober assessment that the industry would ultimately want a more “R idiomatic” solution that took advantage of R naming conventions and did not introduce special requirements for R package maintenance.\nMike Stackhouse noted that a successful pkglite submission would break down a significant barrier to R submissions, but that there were other hurdles. Nevertheless, he asserted that it would be a significant advance to be able to say here is “how” you can do an R submission.\nIt the few minutes that remained, Joe Rickert brought the groups attention to the copy of the word document containing the text of section 4.1.2.10 of the FDA document pertaining to software and asked everyone mark up the document to suggest ideal wording from the industry’s point of view.\nThe group agreed to met next on Friday April 1, at 9AM Pacific time.\nThe zoom recording of this meeting is available here (Passcode: d9N%+JWY)." + "objectID": "minutes/2024-03-01/index.html#rmedicine", + "href": "minutes/2024-03-01/index.html#rmedicine", + "title": "Minutes 2024-03-01", + "section": "R/Medicine", + "text": "R/Medicine\nJoel has been invited to give a talk at the upcoming R/Medicine virtual conference which will be held from June 10 to 14. He is deciding whether to give a talk or a workshop." }, { - "objectID": "minutes/2023-08-04/index.html", - "href": "minutes/2023-08-04/index.html", - "title": "Minutes 2023-08-04", - "section": "", - "text": "View Attendee List\n\n\n\n\n\n\nBen Straub (GSK)\nLi Eva\nChristopher Kania (Biogen)\nEric Nantz (Eli Lilly)\nHyeSoo Cho (FDA)\nJizu Zhi (FDA)\nJoel Laxamana (Roche/Genentech)\nJoseph Rickert (R Consortium)\nNan Xiao (Merck)\nNing Leng (Roche/Genentech)\nPaul Schuette (FDA)\nSam Parmar (Pfizer)\nShannon Lewis (BeiGene)\nStephanie Lussier (Moderna)" + "objectID": "minutes/2024-03-01/index.html#user-2024", + "href": "minutes/2024-03-01/index.html#user-2024", + "title": "Minutes 2024-03-01", + "section": "UseR! 2024", + "text": "UseR! 2024\nThe group decided to submit an abstract for useR!2024 which will be held from July 8 to 11 in Salzburg, Austria. the deadline for the CFP is Sunday, 10 March at 11:59 PM CET (UTC+1)\nAction:\nEric and Ning will draft the abstract." }, { - "objectID": "minutes/2023-08-04/index.html#minutes", - "href": "minutes/2023-08-04/index.html#minutes", - "title": "Minutes 2023-08-04", - "section": "Minutes", - "text": "Minutes\nThe meeting was recorded and the video is available.\n\nPilot 2\n\nHyeSoo Cho reported that she is working with the Pilot 2 re-submission and that it looks good.\nHyeSoo expects that the final on this pilot submission will be available at the end of August.\nEveryone recognized and thanked Eric Nantz for the sustained and last-minute efforts to get the submission out.\n\n\n\nPilot 3\n\nPaul Schuette brought the attention of the group to section 4.i.2.10 of the Study Data Technical Conformance Guide - Technical Specification Document and noted that .r and .zip files are listed as acceptable file formats for submissions.\nAfter some discussion, the WG decided not to use pkglite to wrap the R code as has been done in previous submissions, but to use .r files for the code. (Note that the FDA is unable to use .R internally.)\nPaul noted that the FDA desires submission materials to be applicable for at least six years after submission. This triggered a discussion about possibility of using .zip files to transmit the proprietary packages, instead of pulling them from public GitHub repos as been done so far.\nIn the end, the WG decided to stick with using GitHub repos for Pilot 3 as there is currently no apparent advantage testing the .zip file method at this time.\nJoel Laxama reported that preparations for Pilot 3 are going well, and that a submission using .r files could be made in early September.\nThe WG thought it best to wait for the report of Pilot 2 before submitting Pilot 3.\n\n\n\nPilot 4\n\nEric reported that thanks to the contributions form the Appsilon team significant progress has been made on using both mechanisms for packaging R submissions: Containers and Webassembly.\nAppsilon has a prototype submission using Podman container technology working and has confirmed that it does not cause files to be written to the hard-drive.\nEric and the Appsilon engineers also have a very preliminary prototype of using Webassembly to wrap a small Shiny app working.\nPosit engineers have contributed webr expertise.\nEric is optimistic about having Pilot submissions based on at least one, and possibly both, of these technologies ready by the end of the year.\n\nAction\n\nPaul will confer with the proper FDA authorities to determine what preparations need to be undertaken by the FDA to use the Podman containers.\nEric will invite an Appsilon representative to come to a future meeting of this working group\n\n\n\nJuly 21 San Jose State R Foundation Event\nThe R Foundation SummeR Bay Area R Meetup was held at San Jose State University on July 21. Ning Leng reports that:\n\nThe 50 plus attendees indicated that quite a few Bay Area companies are moving towards using R in preclinical and genomics research.\nRepresentatives from several small CROs attended the meeting.\nR Consortium recognition was not good among this group.\n\nAction\n\nJBR and Ning to discuss what can be done to promote the RC.\n\n\n\nSpeaking Opportunities\n\nEric will submit an abstract to speak about Pilot 3 and Pilot 4 at the R/Pharma virtual conference to be held in on October 24 - 26.\nPaul will be presenting at both at the PHUSE/FDA CSS 2023 conference on September 18 -20 and the ASA Biopharmaaceutical Section Regulatory-Industry statistics Workshop to be held in Rockville, MD on September 27 - 29 and intends to use the activities of this working group as a case study.\nNing suggests that it would be very nice if the RC could hold and R Adoption Webinar in the November time frame to describe the Pilot 2 and Pilot 3 submissions.\n\nAction:\n\nPaul will check with FDA authorities to see whether it is appropriate for the R Consortium to publicize his speaking opportunities on social media.\nJBR will work with the RC Community development committee to make preparations for the promoting the speaking activities and setting up the webinar.\n\nThe next meeting of the Submissions working group will be at 9AM PST on Friday, September 1st." + "objectID": "minutes/2024-03-01/index.html#pilot-4-update", + "href": "minutes/2024-03-01/index.html#pilot-4-update", + "title": "Minutes 2024-03-01", + "section": "Pilot 4 update", + "text": "Pilot 4 update\nAt 38:38 into the video of the meeting, Eric previews the Pilot 4 WebAssembly (Wasm) submission. To be compatible with Wasm, the submission is being built with the Rhino framework for shiny which is different from what was used in Pilot 2 but is functionally equivalent. The screen capture below references the compiling the WebR Wasm submission with shinylive.\n After the build it is necessary to launch a webserver process on your your local setup. The Wasm version of the Shiny app reproduces the teal filters without using teal itself.\n The next step is to test the application on the container approximating the FDA Windows environment.\n\nImmediate Plans\nJoel’s team will continue working on Pilot 3 re-submission with the goal of picking a submission date at the April meeting." }, { - "objectID": "minutes/2024-05-03/index.html", - "href": "minutes/2024-05-03/index.html", - "title": "Minutes 2024-05-03", - "section": "", - "text": "View Attendee List\n\n\n\n\n\n\nEric Nantz (Eli Lilly)\nHeidi Curinckx (Johnson & Johnson)\nHyeSoo Cho (FDA)\nJizu Zhi (FDA)\nJoel Laxamana (Roche/Genentech)\nJoseph Rickert (R Consortium)\nNan Xiao (Merck)\nNing Leng (Roche/Genentech)\nPaul Schuette (FDA)\nRobert Devine (Johnson & Johnson)\nSam Parmar (Pfizer)\nLovemore Gakava\nYoun Kyeong Chang\nThe meeting was recorded and the video is available" + "objectID": "minutes/2024-03-01/index.html#the-submission-environmnt-setup", + "href": "minutes/2024-03-01/index.html#the-submission-environmnt-setup", + "title": "Minutes 2024-03-01", + "section": "The Submission Environmnt Setup", + "text": "The Submission Environmnt Setup\nSetting up the submission environment is a manual process. The WG would like to automate at lest some of this process to ease the burden of setup and improve repeatability. It would be nice to have a GitHub action workflow that uses containers and runs on Azure. This will be a topic for the next meeting.\nAction: JBR will promote this task and try to find a company willing to work on it." }, { - "objectID": "minutes/2024-05-03/index.html#discussion-of-recently-revealed-r-vulnerability", - "href": "minutes/2024-05-03/index.html#discussion-of-recently-revealed-r-vulnerability", - "title": "Minutes 2024-05-03", - "section": "Discussion of Recently Revealed R Vulnerability", - "text": "Discussion of Recently Revealed R Vulnerability\n\nThe working group spent a few moments discussing the recently raveled vulnerability in R as reported in Dark Reading and other online sites and discussed in this infosec exchange.\nThe working group that the incident highlights the need for caution in accepting serialized objects just as one ought to be careful about clicking on any link from an untrusted source.\nIt was noted that our pilot submissions do not directly transmit data sets.\nJBR noted that he has heard the R Foundation is working on an official statement about the incident and that the R Consortium will draw attention to it when it is available.\nThe working group agreed that the incident should be viewed as an “overdue wake up call” and.\nJBR suggested that this might we a good time to see if we could attract R users with security expertise to the R Consortium.\nEric suggested Bob Rudis and and posted this link to a relevant post.\n\nAction: JBR to investigate the possibility of a security focused working group." + "objectID": "minutes/2024-03-01/index.html#swissmedic-wg", + "href": "minutes/2024-03-01/index.html#swissmedic-wg", + "title": "Minutes 2024-03-01", + "section": "Swissmedic WG", + "text": "Swissmedic WG\nJBR asked the WG for help in identifying Europe-based Pharma employees who might be interested in starting a new working group focused on Swissmedic.\nAction: Ning will open an issue on this and tag JBR and Gregory." }, { - "objectID": "minutes/2024-05-03/index.html#pilot-3", - "href": "minutes/2024-05-03/index.html#pilot-3", - "title": "Minutes 2024-05-03", - "section": "Pilot 3", - "text": "Pilot 3\n\nPilot 3 was resubmitted on April 19, 2024 under BLA application number 111111 sequence 0007\nHyeSoo confirmed receipt by the FDA and performed a preliminary analysis.\nHyeSoo’s update begins at 10 minutes, 30 seconds into the video\nHer initial check did not reveal any major issues, but she did have a few minor issues mostly relating to the zip file and file names.\nHyeSoo shared two solutions to the error depicted in the screen capture below.\n\n * There was also an inconsistency with a file name in the submission and the name in the ADRG. * A solution might be to rename the file after submission. * The FDA target date to wrap up the review is early July. * This would enable Ning to include the news the the useR! presentation." + "objectID": "minutes/2024-03-01/index.html#next-meeting", + "href": "minutes/2024-03-01/index.html#next-meeting", + "title": "Minutes 2024-03-01", + "section": "Next Meeting", + "text": "Next Meeting\nThe next meeting of the working group will be on Friday, April 5, 2024 at 9AM PST." }, { - "objectID": "minutes/2024-05-03/index.html#pilot-4", - "href": "minutes/2024-05-03/index.html#pilot-4", - "title": "Minutes 2024-05-03", - "section": "Pilot 4", - "text": "Pilot 4\n\nEric Nantz begins presenting his update on Pilot 4 at 32:35 into the video.\nThe ADRG for Pilot 4 which is almost complete.\nThe following screen capture shows the commands starting wasm in Eric’s Windows VM.\n\n\n\nThe 10GB threshold on etcd gateway mostly to guarantee transfer on first try.\nPilot 4 transfer is approximately 800 MB\nDecision mate to try two ways of building wasm app\nPrebuilt before transfer\nBuilt by FDA after transfer\nSpecified versions of R and RStudio IDE need to be pre-installed.\nThe target for submission is late June or early July after HyeSoo has sent her evaluation of Pilot 3 off for document clearance\nIt might be possible to also submit the docker version of Pilot 4\nPaul will investigate whether docker desktop or docker runtime is possible or preferable." + "objectID": "minutes/2021-02-05/index.html", + "href": "minutes/2021-02-05/index.html", + "title": "Minutes 2021-02-05", + "section": "", + "text": "View Attendee List\n\n\n\n\n\n\n“Joseph Rickert - R Consortium”\n“Adrian Waddell - Roche”\n“Paul Schuette - FDA”\n“Bella Feng - EQRx”\n“Yilong Zhang - Merck”\n“Eric Nantz - Lilly”\n“Doug Kelkhoff - Genentech”\n“Mike Stackhouse - Atorus Research”\n“Nan Xiao - Merck”\n“Ning Leng - Genentech”\n“Sascha Ahrweiler - Bayer”\n“Steven Hasendinckx J&J”\n“Phil Bowsher - RStudio”\n“Bob Engle - Biogen”\n\n\n\n\nJoseph Rickert brought the meeting to order, reminded everyone of the GitHub repo for the working group where minutes and other documents are kept, and summarized the goal articulated in the previous meeting to develop a pilot environment to study approaches for creating R submissions.\nMike Stackhouse noted that the group should focus on creating an environment that was “consumable” by the FDA. Paul Schuette agreed with this. He noted that the experiment he did with Eric Nantz two years ago (discussed in a previous meeting) was the closest he has come so far.\nNext followed a discussion about the FDA computing environment, a discussion thread that developed over the course of the meeting. Some key points are:\n\nFDA reviewers and researchers work primarily on desktop machines that mostly run Windows 10.\nThere are two classes of desktop computers 1) regulatory computers and 2) scientific computers.\nThe scientific computers are not as rigorously controlled as the scientific computers.\nPaul has installed Ubuntu on a few of the scientific computers\nDesktop computers run SAS version 9.4, but the build may differ\nA perceived advantage of SAS is that it generally runs older software\nThere is a pilot project going on at the FDA to run SAS on a server, which would ensure a common build.\nWhen asked: If the FDA decided to move to Linux, how long would it take to convert all of the desktops from Windows to Linux, Paul speculated that it would take a minimum of two years. The implication is that Windows is not going away anytime soon.\nWhen asked about the installation of R packages, Paul indicated that installation was not a problem.\nObtaining R packages is more of an issue. In theory, the FDA could use MRAN or some other repository which enables downloading specific versions of packages.\n\nThe discussion turned to considering section 4.1.2.10 of the Study Data Technical Performance Guide:\n\nYilong Zhang stated that his company has focused on the sentence: “The Specific Software utilized should be specified in the ADRG.” Mike Stackhouse explained that the PHUSE working group is is leading is also focused on interpreting this sentence.\nPaul noted that companies are obligated to use the SAS export file format, but are not obligated to use SAS. Bella Feng noted that a recent FDA oncology pilot explicitly specifies SAS.\nPaul noted that many FDA analyses are hybrid using both SAS and R. The group acknowledge that all R submissions were the ultimate goal, we should be planning to work with mixed submissions for some time.\nMike Stackhouse stated that, although there are many corner cases, we should focus on building a reference platform along the lines of least resistance and go for what is easily achievable. The group generally agreed with this.\nTowards the end of the meeting Paul mentioned that although the that section 4.1.2.10 specifies that programs should be submitted as text files, it does not mean that .txt extensions must be used. This surprised everyone. When asked if the FDA document could be revised to make this more clear, Paul stated that it was possible. He said that the document is generally revised once or twice a year, the most recent revision is dated Nov 20, 2020.\nAction Item: Paul stated that if the group wanted to suggest the wording to revise the document, he would submit it to the responsible FDA committee. He noted that to make the change it would need to be approved by the committee and go through the normal approval process.\nJoseph Rickert asked the group to use the repo to submit their suggested changes to the wording about using text, and reminded everyone that the next meeting was set for Friday, March 5, 2021.\nJoseph Rickert, Mike Stackhouse and Sascha Ahrweiler agreed to meet before the next Submissions group meeting to try and map out the various PHUSE, PSI and R Consortium working groups that are doing similar or complementary work.\nThe link to the video of the meeting is: https://zoom.us/rec/share/gFQancacysPFHm0Czrw3sAYOCrt35BgTbcodBdY2LGld4fkykDypkL99PX5o0i-c.JRCWwmZfO9Ui8G6f\nPasscode: +GKR9&i6" }, { - "objectID": "minutes/2024-05-03/index.html#adrg-standard", - "href": "minutes/2024-05-03/index.html#adrg-standard", - "title": "Minutes 2024-05-03", - "section": "ADRG Standard", - "text": "ADRG Standard\n\nThere is a proposal that the RC investigate setting up a working group for drafting an ADRG standard for R.\nWe will open up an issue o the submissions-wg repository to capture ideas members may want to contribute and then discuss the proposal at our next meeting." + "objectID": "minutes/2021-06-04/index.html", + "href": "minutes/2021-06-04/index.html", + "title": "Minutes 2021-06-04", + "section": "", + "text": "View Attendee List\n\n\n\n\n\n\n“Sascha Ahrweiler - Bayer”\n“Ethan Chen - FDA”\n“Heather Crandall - FDA”\n“Bob Engle - Biogen”\n“Bella Feng -”\n“Steven Hasendinckx - J&J”\n“Chris Kania - Biogen”\n“Doug Kelkhoff - Genentech”\n“Ning Leng - Genentech”\n“Tadeusz Lewandowski - Roche”\n“Eli Miller - Atorus”\n“Eric Nantz - Lilly”\n“Joseph Rickert - R Consortium”\n“Paul Schuette - FDA”\n“Ojesh Upadhyay - GSK”\n“Adrian Waddell - Roche”\n“Nan Xiao - Merck”\n“Jiang Xu - FDA”\n“Yilong Zhang - Merck”\n\n\n\n\nNote that the bold numbers in the minutes are time stamp references for the video recording.\nJoseph Rickert opened the meeting by welcoming guests from the FDA Ethan Chen, Heather Crandall and Jiang Xu and giving brief description of the R Consortium and its mission.\nJoe then summarized the purpose of the meeting: the Submissions working group is working on a pilot submission to the FDA that would test whether an “all R” submission could pass the submssions process and be easily consumable by the FDA reviewers. Furthermore, the group would like to have the R Consortium act as the sponsor of the pilot submission, and is looking for guidance to determine if this is possible.\n6:31 Ethan Chen expressed a desire to support the R Consortium initiative and mentioned that R is currently included as a supported file eCTD file format. See Specifications for File format Types Using eCTD Specifications.\n15:00 1. Test the exchange mechanism through the gateway and routing to the specific in the review division 2. Once received, can they be open and reviewed\nEthan stated that his team is involved mainly with the exchange method.\n15:30 In general, to initiate an a submission in a production environment an organization must open an ESG Accoount. This process includes requesting an account and writing a Non-Repudiation letter to the FDA. (See the AS2 Account Checklist). The FDA then will assign an application number.\n19:32 Doug Kelkhoff asks if it is possible for a non-profit such as the R Consortium could be a sponsor. Jiang Xu believes it is possible but will require further discussion.\n22:40 Adrian Waddell describes the interplay of the exchange and review processes.\n23:00 Ethan Chen outlines two major concerns:\n\nSecurity (Executable files not accepted)\nTo meet the error records management requirement the FDA must be able to open any submitted file for the entire retention period which could be up to 30 years.\n\n26:00 Joe ask Ethan if there is someone in particular who could help setting up the ESG account. Ethan replies that Heather and Jiang could help and also help to determine if the R Consortium could be a sponsor.\n26:55 Heather Crandall recommends becoming familiar with the requirements on the ESG Webpage.\n28:00 Doug Kelkhoff initiates a discussion of the challenges that the working group is hoping to address.\nThe ask right now is for the working group to understand what steps we must undertake and who would be our FDA contact is we get stuck.\n30:15 Jiang Xu states that the FDA would want to know exactly what things we think the FDA would need to test and notes that different FDA offices and centers would need to be involved.\n34:00 Yilong Zhang points out that a goal of the working group is to test how internally R packages could be transmitted to the FDA as part of a submission.\n35:25 Doug Kelkhoff describes challenges including file extensions and case sensitivity\n36:55 Adrian Weddell notes that if the working group is able to successfully make a pilot submission and put it out in the open it would provide a guide for other companies to follow. He also raised the issue of probing the security issues around the way R packages often require dependent packages to be installed.\n40:10 Bell Feng compares an R script to a SAS macro and asks for clarification about how we are using packages. Doug Kelkhoff clarifies that the issue is about the using R best practices and being able to install packages required to perform and analysis and not just submit R scripts.\n50:00 Joe asks if there are any other FDA offices or groups that the working group should contact. Jiang and Heather do not think any other contacts are necessary to contact at this time. Jiang indicates that they will discuss this within the FDA.\nThe group agreed to meet next on Wednesday June 30, 2021.\nThe video of the meeting is available here Passcode: V@.?eq85\nAction Items for the Working Group\n\nGenerate a list of potential issues and items that we think the FDA will want to evaluate.\nBecome familiar with process and requirements for opening an ESG account as described on the Electronic Submissions Gateway site." }, { - "objectID": "minutes/2024-05-03/index.html#recording-chat-file-contents", - "href": "minutes/2024-05-03/index.html#recording-chat-file-contents", - "title": "Minutes 2024-05-03", - "section": "Recording Chat File Contents", - "text": "Recording Chat File Contents\n\n00:08:01 Sam Parmar: Reacted to “https://infosec.exch…” with 👍🏽\n00:10:01 Eric Nantz: This is another balanced take https://aitap.github.io/2024/05/02/unserialize.html\n00:10:06 Sam Parmar: Reacted to “This is another bala…” with 👍🏽\n00:11:44 Sam Parmar: The Python pickle modules has a very similar situation. https://docs.python.org/3/library/pickle.html\n00:12:04 Sam Parmar: That blog post Eric linked mentions it.\n00:17:11 Eric Nantz: https://rud.is/b/2024/05/03/cve-2024-27322-should-never-have-been-assigned-and-r-data-files-are-still-super-risky-even-in-r-4-4-0/\n00:17:15 Sam Parmar: Reacted to “https://rud.is/b/202…” with 👍🏽\n00:33:52 laxamanj: See Note from Pilot 1 submission : https://github.com/RConsortium/submissions-pilot1-to-fda/blob/main/m1/us/report-tlf.pdf\n00:40:28 Eric Nantz: Pilot 4 Readme: https://github.com/RConsortium/submissions-pilot4-webR\nPreview version of the Pilot 4 Analysis Data Reviewer Guide (ADRG):\nHTML Format: https://rpodcast.quarto.pub/pilot4-webassembly-adrg/\nPDF Format: https://rsubmission-draft.us-east-1.linodeobjects.com/adrg-quarto-pdf.pdf\n00:52:13 Sam Parmar: Hi Eric. Did we run mention this issue? https://github.com/RConsortium/submissions-pilot4/issues/5" + "objectID": "minutes/2023-05-05/index.html", + "href": "minutes/2023-05-05/index.html", + "title": "Minutes 2023-05-05", + "section": "", + "text": "View Attendee List\n\n\n\n\n\n\nAndrew Borgman (Bristol Myers Squibb)\nBen Straub (GSK)\nBrandon Suchon\nEric Nantz (Eli Lilly)\nHyeSoo Cho (FDA)\nJizu Zhi (FDA)\nJoel Laxamana (Roche/Genentech)\nJoseph Rickert (R Consortium)\nKui Shen (Bayer)\nNan Xiao (Merck)\nNate Mockler (Biogen)\nPaul Schuette (FDA)\nRenping Zhang (Johnson & Johnson)\nRobert Devine (Johnson & Johnson)\nSaghir Bashir (Argenx)\nSam Parmar (Pfizer)\nSean Healey (Pfizer)" }, { - "objectID": "minutes/2024-05-03/index.html#next-meeting", - "href": "minutes/2024-05-03/index.html#next-meeting", - "title": "Minutes 2024-05-03", - "section": "Next Meeting", - "text": "Next Meeting\nThe next meeting of the working group will be at 9AM Pacific Time on Friday June 7, 2024." + "objectID": "minutes/2023-05-05/index.html#add-minutes-here", + "href": "minutes/2023-05-05/index.html#add-minutes-here", + "title": "Minutes 2023-05-05", + "section": "Add Minutes Here", + "text": "Add Minutes Here\nThe meeting was recorded and the video is available.\nJoseph Rickert brought the meeting to order.\n\nPilot 2\n\nHye Soo Cho of the FDA reported that her review of the Pilot 2 submission is going well and that she expects to be finished in June.\nShe is not sure how long it will take the FDA to produce a written response.\n\n\n\nPilot 3\nJoel Laxamana reported on Pilot 3 work.\n\nThe execution team isfocusing on documentation particularly in the ADRG.\nThe WG confirmed that Pilot 3 should follow the Pilot 2 approach and send the renv.lock file in the R package text.\nThere was a question about SDTM Versions. The WG confirmed that the Pilot 3 should use the same 1.4 STDM version as Pilots 1 and 2. See Issue #104.\nQC Findings will go as Appendix to the ADRG.\nThe WG agreed that the second week in July would be a good target for Pilot 3 Submission.\n\n\n\nPilot 4\nEric Nantz provided an update on Pilot 4 work.\n\nEric expects to have the first meeting of the execution team volunteers in the next few weeks.\nEric is taking a step back from committing to a container based approach in order to consider the possibility of using a self executing app in the browser using WebAssembly.\nGeorge Stagg from Posit is providing some assistance.\nThe idea is that the R submission code would run in a browser on the local machine of an FDA analyst.\nPaul Schuette indicated that this approach would likely be possible at the FDA.\nEric said that he would be happy to try and replicate the FDA web browser environment.\nThe group suggested that a Webinar for the R Adoption series and other venues would be valuable for promoting the project.\nPaul speculated that this web browser technology might also be useful to FDA field inspectors.\nEric noted that a selection core of R packages is being identified to have them run run “out of the box”.\nIf you would like to be part of the Pilot 4 team please contact Eric Nantz.\nPaul noted that recent events where outside entities can re-litigate FDA approvals decades after the approval could make it even more necessary to be able to run analysis software many years after the submission.\nJBR surmised that there may be interest in WG to explore long term archiving.\n\n\n\nOther discussions\n\nNan Xiao brought attention to a document describing the submission WG in Japan. It refers to a survey about open source that mentions the Pilot 1 Submissions.\nWe are exploring the possibility of arranging for the authors of this document to participation in an R Adoption Series webinar.\n\nThe next meeting of the Submissions WG will be on Friday, June 2, 2023 at 9AM Pacific Time." }, { - "objectID": "minutes/2022-06-04/index.html", - "href": "minutes/2022-06-04/index.html", - "title": "Minutes 2022-06-04", + "objectID": "minutes/2023-11-03/index.html", + "href": "minutes/2023-11-03/index.html", + "title": "Minutes 2023-11-03", "section": "", - "text": "View Attendee List\n\n\n\n\n\n\nBob Engle (Biogen)\nEllis Hughes (GSK)\nGabriel Becker (Roche/Genentech)\nGregory Chen (MSD)\nJizu Zhi (FDA)\nJoseph Rickert (R Consortium)\nKui Schen (Bayer)\nMichael Blanks (BeiGene)\nNan Xiao (Merck)\nPhanikumar Tata (Syneos Health)\nPhil Bowsher (Posit)\nRobert Devine (Johnson & Johnson)\nRyan Johnson (Posit)\nSean Healey (Pfizer)\nSteven Hasendinckx (Johnson & Johnson)\nTadeusz Lewandowski (Roche/Genentech)\nXin Qiu (Johnson & Johnson)\n\n\n\n\nUnfortunately, the video of the meeting is not available.\nJBR began the meeting with this agenda:\n\nPilot 2 Status Update\nR Adoption Webinar\nPilot 3 Status?\nJapan Submission Status?\nChina Submission Status?\nReview project Board\nOpen Discussion\n\n\nPilot 2 Status\nThe following status was provided in an email to JBR by Ning Leng\n\nThe Pilot 2 team is addressing feedback from this working group\nThe Roche “NEST” software, which includes the teal package, is scheduled to be open sourced in mid June.\nAfter teal open source: Pilot 2 team will package up the shiny app code using the golem package.\nPilot 2 is on track for July Submission\n\nJBR asked the following questions:\n\nWill teal be put on CRAN?\nIs the gateway ready?\nIs the cover letter for Pilot 2 fine?\n\nNo one present was sure whether the teal package would be submitted to CRAN before the submission or whether the Pilot 2 submission would be made with this package on GitHub. Tad L. noted teal will have an Apache 2.0 license.\nTad Lewandowski noted that the Pilot 2 execution team received several helpful comments on the shiny app. The team plans to keep the initial app as simple as possible and will consider the ideas proposed in the comments as extensions for the future. He also noted hat the Roche team has built additional shiny apps that have been made public and are available for use in future submissions that collectively form a “clinical studies results viewer”. These include:\n\nEfficacy\nExploratory\nSafety\n\nThe next meeting of the execution team will be on 6-16-2022\n\n\nR Adowtion Series Webinar\nThe next R Consortium R Adoption series webinar will feature the work of the Submissions Working group The tentative agenda for the 2022 July R Adoption webinar is:\n\nTentative date: July 14\nMeeting length: 1.5 hr\nOpening (5min) - Coline, R consortium/Roche\nPresentation: Achieving Regulatory Approval Using R (20min) Tae Hyun Jung, FDA\nPresentation: Review experience of the R consortium R submission pilot 1 (20min) Hye Soo Cho, FDA\nPanel discussion (45min)\nModerator: Ning Leng, R consortium/Roche\nPanelists: Paul Schuette, Hye Soo Cho, and Tae Hyun Jung\n\n\n\nPilot 3\nJBR asked the group to begin thinking about Pilot 3. He noted that we had been thinking about using container technology in a submission, but the WG has not completed its investigation into container technology and the FDA does not appear to be ready for such a submission.\nTad suggested that questions about the content of a Pilot 3 submission would be appropriate for the panel discussion of the upcoming webinar.\n\n\nJapan Submission\nTad and his colleagues have had a paper accepted for the upcoming DIA Conference.\n\n\nChina Submission\nNo update.\n\n\nGeneral Discussion\nThe group then updated the project kanban board moving the shiny documentation to the “In Progress” column.\nThe discussion then turned towards considering the topic of HTA, Health Technology Assessment submissions that was considered in our previous meeting. We are only at the beginning stages and need discuss which European agency we would like to target and what we could bring to the HTA process. As was noted at our previous meeting, NICE in the U.K. and IQWIG in Germany are the primary candidates.\nAction HTA submissions will be a topic for the July Meeting. Tad Lewandowski will ask his colleague Christian Buehrer to speak about Roche’s efforts in this area.\nGregory Chen noted that several members of the WG have expressed in interest in HTA submissions. He also suggested that it would be very helpful to involve experts in this area to assist us.\nAction Gregory agreed to take the lead on compiling a list of experts whose participation could help the working group.\nAction Once the list is available, JBR agreed to contact people on the list to seek their participation.\nThe next meeting of the WG will be at 9AM Pacific Time, on Friday July 1, 2022." + "text": "Minutes prepared by Joseph Rickert and Joel Laxamana.\n\n\n\n\n\n\nView Attendee List\n\n\n\n\n\n\nBen Straub (GSK)\nDadong Zhang (Illumina)\nEric Nantz (Eli Lilly)\nHyeSoo Cho (FDA)\nJizu Zhi (FDA)\nJoel Laxamana (Roche/Genentech)\nKaushal Shah\nNan Xiao (Merck)\nPaul Schuette (FDA)\nRobert Devine (Johnson & Johnson)\nSaghir Bashir (Argenx)\nSam Parmar (Pfizer)\nJoseph Rickert (ProCogia)\nIsmael Alejandro Rodriguez Rodriguez (Appsilon)\nYilong Zhang (Meta)\nYounKyeong Chang\n\n\n\n\nThe meeting was recorded and the video is available.\n\nFDASA Presentation\n\nThe FDASA would like to invite the R Consortium to present at their meeting on December 11, 2023 (3 to 4:30PM ET).\nHowever the FDASA would like to extend an informal invitation rather than formally sponsor the event which would require administrative approvals\nThe RC would still be able to advertise that Paul and HyeSoo are speaking\nThe RC would conduct the event which is expected to attract at least 200 of the approximately 400 FDASA participants.\nRegistration of the event is not required\nThe RC can also invite the general public to attend. (JBR will confer with Ning and Eric about doing this.)\nJBR will s=send an invitation to the event, which should include the abstract, to Paul to be used to invite FDASA members to the event through internal channels.\n\n\n\nPilot 3\nHeySoo and Paul provide some preliminary comments regarding their evaluation of Pilot 3. An extensive discussion starts approximately 12 minutes into the video recording.\n\nThe ADRG states that Pilot 3 was uses R 4.2.3. However, FDA may test using different R versions. (i.e. one reviewer using Rv4.2.1 and other using Rv4.2.3). There are at least two kinds of workstations used by FDA reviewers. Reviewers with “scientific workstations” may have administrative privileges and be able to install R. Users on other “regulatory” workstations will most likely use the version of R installed by IT.\nThe Pilot 3 package didn’t install using renv::install() when using Rv4.2.1, but did install when the reviewer was using Rv4.2.3.\nThe submissions programs which process ADaM data were not updated to match the file adam-pilot-3.xlsx which was included in the submission.\nReviewers were able to update the file name. When they did so the adsl.r ran fine.\nDo not include notes to change the path to source data file in the ADRG steps. Instead, keep a note open to advise reviewers that they “should change the source data path to the location where the data was downloaded from the EDR”.\nThe submission documentation should include the version of the Microsoft operating system used along with the the version of the RStudio IDE used.\nSponsors using proprietary software also encounter Operating system issues. There may also be issues with respect to a difference in the size and power of the computers used by the sponsors and those available to the FDA reviewers.\nThere may be problems if file names using upper case letters are used in submissions. The FDA technical conformance guide specifies the use of lower case letters.\n\nThe next meeting of the Submissions WG will be held at 9AM Pacific Time on Friday, December 8, 2023." }, { "objectID": "minutes/2023-02-03/index.html", diff --git a/sitemap.xml b/sitemap.xml index 6a55a03..6f1aa9d 100644 --- a/sitemap.xml +++ b/sitemap.xml @@ -2,210 +2,214 @@ https://rconsortium.github.io/submissions-wg/minutes.html - 2024-05-16T16:49:42.480Z + 2024-06-07T23:41:04.004Z https://rconsortium.github.io/submissions-wg/minutes/2022-12-02/index.html - 2024-05-16T16:49:42.484Z + 2024-06-07T23:41:04.008Z https://rconsortium.github.io/submissions-wg/minutes/2023-07-07/index.html - 2024-05-16T16:49:42.488Z + 2024-06-07T23:41:04.012Z https://rconsortium.github.io/submissions-wg/minutes/2023-12-01/index.html - 2024-05-16T16:49:42.488Z + 2024-06-07T23:41:04.012Z https://rconsortium.github.io/submissions-wg/minutes/2020-12-04/index.html - 2024-05-16T16:49:42.480Z + 2024-06-07T23:41:04.004Z https://rconsortium.github.io/submissions-wg/minutes/2021-04-05/index.html - 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