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