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: