R pilots

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.

Key evaluation aspects:

Data and analysis scope:

Success Criteria:

Timeline: - Submitted 2021 Nov (v0.1.0) - FDA first response 2021 Nov - Resubmission 2022 Feb (v0.1.0)

Links:

R Submission Pilot 1 Development Repo

R Submission Pilot 1 eCTD Submission Package to FDA

Additional Activities - explore pilot submissions to other HAs (Japan, China)

Key team members:

Developer team:

Ning Leng, Heng Wang (Roche)
Mike Stakehouse, Eli Miller (Atorus)
Yilong Zhang, Peikun Wu (Merck)

Esub team:
Beverly Chin (Roche)
Tim Powell (Biogen)

FDA Staff:
Paul Schuette
Hye Soo Cho

Pilot 2 - shiny submission

Goal: Example R based submission contains a shiny app, submission through the current FDA e-submission system and process

Key evaluation aspects:

Timeline: 2022 H1

Data and analysis scope:

Links:

R Submission Pilot 2 Development Repo

R Submission Pilot 2 eCTD Submission Package to FDA

Key team members: Developer team:

Ning Leng, Heng Wang (Roche)
Mike Stakehouse, Eli Miller (Atorus)
Yilong Zhang, Gregery Chen (Merck)
Eric Nantz (Eli Lilly)

FDA Staff:
Paul Schuette
Hye Soo Cho

Pilot 3 - alternative formats

Goal: Example R based submission exploring alternative options than current FDA e-submission system and process (e.g. container) Timeline: TBD

Developer team:

Eric Nantz (Eli Lilly)