Conference Program Home
My Program
All Times EDT
Legend:
CC = Walter E. Washington Convention Center M = Marriott Marquis Washington, DC
* = applied session ! = JSM meeting theme
Activity Details
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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491 * !
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Thu, 8/11/2022,
8:30 AM -
10:20 AM
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CC-102A
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Bridging Causal Inference and Clinical Trials — Invited Papers
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Society for Clinical Trials, Biometrics Section, Biopharmaceutical Section
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Organizer(s): Fan Li, Duke University
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Chair(s): Fan Li, Duke University
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8:35 AM
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Model-Assisted Analyses of Cluster-Randomized Experiments
Peng Ding, University of California Berkeley
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9:00 AM
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Combining Trial and Population Data to Estimate Population Average Treatment Effects
Elizabeth Stuart, Johns Hopkins University
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9:25 AM
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Sensitivity of Causal Estimands in Clinical Trials with Imperfect Compliance
Heng Chen, Gilead Sciences, Inc.; Daniel F. Heitjan, Southern Methodist University
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9:50 AM
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Clarifying Selection Bias in Cluster Randomized Trials: Estimands and Estimation
Presentation
Fan Li, Yale School of Public Health; Georgia Papadogeorgou, University of Florida; Fan Li, Duke University
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10:15 AM
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Floor Discussion
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537 * !
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Thu, 8/11/2022,
10:30 AM -
12:20 PM
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CC-202A
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Recent Developments in Causal Inference with Real World Evidence in Drug Development — Invited Papers
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Biopharmaceutical Section, Biometrics Section, Society for Clinical Trials
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Organizer(s): Margaret Gamalo , Pfizer Inc.
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Chair(s): Birol Emir, Pfizer Inc
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10:35 AM
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Target Trials: Emulating RCTs Using Observational Longitudinal Data
James M Robins, Harvard University
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11:00 AM
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Targeted Learning of Causal Effects with Continuous Time-to-Event Outcomes
Mark Van der Laan, University of California Berkeley
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11:25 AM
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Regulatory Considerations on the Use of Machine Learning for Real-World Evidence Studies
Hana Lee, FDA
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11:50 AM
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Discussant: Demissie Alemayehu, Pfizer Inc.
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12:10 PM
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Floor Discussion
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