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