Minutes 2026-01-09

Author

Eric Nantz

Published

January 9, 2026

  • Ben Straub (GSK)
  • Eric Nantz (Eli Lilly)
  • HyeSoo Cho (FDA)
  • Ning Leng (Roche/Genentech)
  • Paul Schuette (FDA)
  • Phanikumar Tata (Syneos Health)
  • Phil Bowsher (Posit)
  • Robert Devine (Johnson & Johnson)
  • Sam Parmar (Pfizer)
  • Jared Woolfolk (Cytel)
  • Yilong Zhang (Meta)
Note

The creation of these meeting minutes was supported by the use of a large-language model (LLM)

Agenda

  • Update on Pilot 4 (container / WebAssembly) review report status
  • Pilot 5 (DatasetJSON) re-submission update
  • Pilot 6 (AI-generated programming) status and communication update on early progress (i.e. blog post)
  • Pilot 7 (Realistic Submission Data) - Review synthetic data repositories and kick off planning for sub-team

Pilot 4

  • FDA’s formal review report is still in progress
  • The report will be shared via email before the next working group meeting in February
  • Discussion about an XML file issue that appeared during the Pilot 4 submission process - Eric and Ben plan to follow up with Beverly to investigate why this occurred

Pilot 5

  • Ben is preparing to resubmit Pilot 5 after removing the RDS data file objects
  • The PR is ready and awaiting final steps from Beverly at Roche for submission
  • Expected to be submitted by Monday (January 12, 2026)
  • The submission script may need updates to remove references to the old RDS files
  • Ning Leng has left Roche but will continue involvement in the working group in her new role

Pilot 6

  • Officially focusing on AI-generated programming to build out all datasets from the original CDISC pilot
  • This is NOT a formal submission to FDA - it’s an exploratory effort to create a more comprehensive submission package
  • Team is leveraging various AI platforms (GitHub Copilot, KG AI, Conviva) to assist with programming
  • Meetings moved to Zoom platform and occur every Friday at 10 AM Eastern Time
  • Open to anyone interested in participating - join via the R Consortium calendar link
  • Discussion about creating a blog post to publicize early progress
  • Current submission package is small (5 datasets, 3 tables, 1 figure) - Pilot 6 aims to expand this

Pilot 7

  • New pilot focusing on realistic submission data for Phase 3 trials
  • Yilong Zhang connected the group with OpenClinica for synthetic data
  • Initial synthetic dataset (8MB XML file) now available in GitHub repository
  • New Slack channel created: “Pilot 7 Benchmark Data”
  • Eric will organize a sub-team with dedicated meeting times (weekly or bi-weekly)
  • First task is to evaluate the OpenClinica synthetic data and determine if additional data sources or simulation approaches are needed
  • Team will explore using AI to convert XML data into tidy datasets

Website Updates

  • Ben encouraged contributions to improve the R Consortium Submissions Working Group website
  • Suggested additions include a timeline of the group’s history and integration of hex stickers created by J&J colleagues
  • The repository is public and open to contributions via pull requests