Minutes 2025-06-06

Author

Eric Nantz & Theresa Christiani

Published

June 6, 2025

  • Ben Straub (GSK)
  • HyeSoo Cho (FDA)
  • Jared Woolfolk
  • Joel Laxamana (Roche/Genentech)
  • Keaven Anderson (Merck)
  • Paul Schuette (FDA)
  • Ning Leng (Roche)
  • Saghir Bashir (Argenx)
  • Sam Parmar (Pfizer)
  • Youn Kyeong Chang (FDA)
  • Terry Christiani

Pilot 4

  • Hye Soo provided an update on high level feedback of current pilot 4 submission
  • some discrepancy were found between the ADRG and the actual github folder structure, etc
  • outdated links were noticed in ADRG (e.g. https://cran.r-project.org/bin/windows/base/old/4.4.1/, moved from base/ to base/old/)
  • Hye Soo will work with Eric offline on the re-submission
  • Some issues Hye Soo encountered may be due to windows system versioning. If needed, we will engage more WG members to test the submission bundle using different windows versions.

Pilot 5

  • Part 1 is near completion (reproduce pilot 3 contents but in json format)
  • Pilot 5 team will submit part 1 to FDA in late July. Will confirm the submission date in the July WG meeting.
  • The Pilot 5 team will initiate a discussion on the scope of pilot 5 part 2. In part 2, we will cover more complicated TLFs, and more ADaM data sets to make the submission closer to a real submission.
  • Eli implemented two QC bots for pilot 5 using github actions. One uses diffdf to check consistencies between pilot3 data and pilot 5 data; the second bot uses llm to check consistencies between pilot 3 graphs and pilot 5 graphs.
  • Ning used LLM to generate three tables of the ADRG PR. The LLM generated, human reviewed tables will be included in pilot 5 ADRG
  • When generating new codes for pilot 5 part 2, the team may also consider using code assistants to write the first line code. (Roche is exploring building customized bots for admiral and NEST) ## Pilot 6
  • Keaven suggested exploring submission of html in pilot 6. The proposed scope is having an interactive report to assist review - especially for large tables such as AE tables, be able to drill down to specific terms and display listing of patients involved
  • Hye Soo and Paul commented that they are happy to explore the review of html as a supplementary material to the primary pdf file
  • will also explore submitting html version of ADRG
  • The pilot 5 team will align their part 2 scope to pilot 6 proposal, to make sure we maximize the reusability of the codes
  • Keaven will reach out to Merck individuals to seek interest of participation

Pilot 5 lessons learned webinar

  • We will host a R consortium webinar with the pilot 5 team. The focus will be on 1) how to use git efficiently among a relatively large team of collaborators, 2) the usage of github actions to build automated QC bots
  • Terry, Ning and Ben will organize the event

Hex stickers

  • Ben will finalize the design of the Hex stickers
  • Terry will help printing out the stickers and send to key WG members to distribute at conferences

SCE blog #2

  • Jared asked whether there are any discussions on producing a whitepaper on container management (example topic: for a long running trial, what are the suggestions on when to upverison the container)
  • As we are at a very early stage of exploring of the usage of container in regulatory submission, we will start with a few interviews with big pharma and produce a blog post (similar to this one)
  • Jared agreed to lead this effort