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CC = Walter E. Washington Convention Center   M = Marriott Marquis Washington, DC
* = applied session       ! = JSM meeting theme

Activity Details

12 * ! Sun, 8/7/2022, 2:00 PM - 3:50 PM CC-206
Opportunities and Challenges in the Use of External Control Arms in Drug Development — Invited Papers
Biopharmaceutical Section, Biometrics Section, Society for Clinical Trials
Organizer(s): Antara Majumdar, GSK
Chair(s): Antara Majumdar, GSK
2:05 PM Leveraging External Data to Augment the Control Arm in Randomized Clinical Trials
Ram Tiwari, Bristol Myers Squibb
2:30 PM Propensity-Score-Integrated Priors: A Novel Strategy for Leveraging Real-World and Historical Data
Junjing Lin, Takeda Pharmaceuticals; Margaret Gamalo , Pfizer Inc.; Ram Tiwari, Bristol Myers Squibb
2:55 PM Learnings from Regulatory Feedback on RWE in Regulatory Submissions
Prashni Paliwal, Flatiron Health
3:20 PM External Control Arm (ECA) in Oncology Studies
Helen Zhou, GSK; Antara Majumdar, GSK; Andrew Smith, GSK; Brielle Forsthoffer, GSK; Nicky Best, GSK; Tai-Tsang Chen, GSK
3:45 PM Floor Discussion
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