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189 * ! Tue, 8/10/2021, 1:30 PM - 3:20 PM Virtual
SBR Showcase: Recent Advances in Statistical Methodology for Medical Product Development — Invited Papers
Statistics in Biopharmaceutical Research Journal
Organizer(s): Frank Bretz, Novartis AG; Toshimitsu Hamasaki, George Washington University Biostatitics Center
Chair(s): Frank Bretz, Novartis AG
1:35 PM Causal Inference and Estimands in Clinical Trials
Ilya Lipkovich, Eli Lilly; Bohdana Ratitch, Bayer; Craig Mallinckrodt , Biogen Idec
2:05 PM Innovation in Designing Clinical Trials: The Role of Simulation
Cristiana Mayer, Janssen R&D
2:35 PM 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
3:05 PM Floor Discussion