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CC = Walter E. Washington Convention Center M = Marriott Marquis Washington, DC
* = applied session ! = JSM meeting theme
Activity Details
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12 * !
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Sun, 8/7/2022,
2:00 PM -
3:50 PM
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CC-206
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Opportunities and Challenges in the Use of External Control Arms in Drug Development — Invited Papers
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Biopharmaceutical Section, Biometrics Section, Society for Clinical Trials
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Organizer(s): Antara Majumdar, GSK
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Chair(s): Antara Majumdar, GSK
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2:05 PM
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Leveraging External Data to Augment the Control Arm in Randomized Clinical Trials
Ram Tiwari, Bristol Myers Squibb
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2:30 PM
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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
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2:55 PM
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Learnings from Regulatory Feedback on RWE in Regulatory Submissions
Prashni Paliwal, Flatiron Health
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3:20 PM
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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
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3:45 PM
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Floor Discussion
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Video Available to all JSM Registered Attendees. Please login to view.
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