Background

Pilot principles:

Provide open examples of submitting R-based clinical trial data/analysis packages to FDA.

• All pilots will be submitted from R consortium (non-profit identity) to FDA. Simulated data will be used.
• All data, codes and documents will be fully available to public.
• FDA Staff will be engaged to reproduce analysis results.
• Submitter and FDA Staff will provide feedback on current process/system
• Contributions from multiple companies/organizations are preferred. Avoid bias to any company/organization specific tools.

You can view more details about each of the current pilots by visiting their dedicated pages below:

• Pilot 1: Common analyses
• Pilot 2: Shiny application submission
• Pilot 3: ADaM datasets
• Pilot 4: Alternative formats
• Pilot 5: DatasetJSON
• Pilot 6: AI-assisted ADaM and TLF generation
• Pilot 7: Synthetic clinical trial data

NEWS

Date	Post Title
Upcoming	Beyond Feasibility: Learning from FDA’s Response to WebAssembly and Container-Based Submissions
02/13/2026	R Submissions Working Group: 2026 Plans and 2025 Success
12/15/2025	Johnson & Johnson’s Success Story: A Hybrid R/SAS Strategy for FDA Submission
12/08/2025	Expanded FDA eCTD File Format Support for R Packages — A Milestone Achieved Through Industry–FDA Collaboration
02/28/2025	R Submissions Working Group: Pilot 5 Launch and more!
10/09/2024	Using R to Submit Research to the FDA: Pilot 4 Successfully Submitted to FDA CDER
08/26/2024	News from R Submissions Working Group – Pilot 3 Successfully Reviewed by FDA
07/02/2024	R Consortium’s Submission Working Group: Advancing R for Regulatory Success at PharmaSUG 2024
05/29/2024	Enhancing Clinical Trial Data Sharing with R Consortium’s R Submissions Working Group
05/29/2024	One More Step Forward: Presentation to Swissmedic on Regulatory Submission using R and Shiny