R-based Clinical Trial Regulatory Submission Working Group

The R submission working group is a cross industry pharma working group focusing on improving practices of R-based clinical trial regulatory submission. The R submission working group is under R consortium.

Our Mission

Pilot principles:

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

Pilot 1 - common analyses

Goal: Example R based submission contains common analyses, submission through the current FDA e-submission system and process (e.g. codes will be submitted as .txt files).

Key evaluation aspects:

Data and analysis scope:

Success Criteria:

Timeline: 2021 H2

Pilot 2 - advanced analyses

Goal: Example R based submission contains advanced analyses, submission through the current FDA e-submission system and process (e.g. codes will be submitted as .txt files).

Key evaluation aspects:

Timeline: 2022 H1

Pilot 3 - alternative formats

Goal: Example R based submission exploring alternative options than current FDA e-submission system and process (e.g. codes be submitted in .r format).

Timeline: TBD