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* = applied session ! = JSM meeting theme
Activity Details
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189 * !
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Tue, 8/10/2021,
1:30 PM -
3:20 PM
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Virtual
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SBR Showcase: Recent Advances in Statistical Methodology for Medical Product Development — Invited Papers
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Statistics in Biopharmaceutical Research Journal
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Organizer(s): Frank Bretz, Novartis AG; Toshimitsu Hamasaki, George Washington University Biostatitics Center
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Chair(s): Frank Bretz, Novartis AG
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1:35 PM
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Causal Inference and Estimands in Clinical Trials
Ilya Lipkovich, Eli Lilly; Bohdana Ratitch, Bayer; Craig Mallinckrodt , Biogen Idec
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2:05 PM
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Innovation in Designing Clinical Trials: The Role of Simulation
Cristiana Mayer, Janssen R&D
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2:35 PM
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Some Considerations on Design and Analysis Plan on a Nonrandomized Comparative Study Using Propensity Score Methodology for Medical Device Premarket Evaluation
Nelson Lu, FDA/CDRH; Yunling Xu, CDRH/FDA; Lilly Q. Yue, FDA/CDRH
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3:05 PM
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Floor Discussion
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