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CC = Baltimore Convention Center,    H = Hilton Baltimore
* = applied session       ! = JSM meeting theme

Activity Details

624 * Thu, 8/3/2017, 8:30 AM - 10:20 AM CC-329
Trial Design and Analysis Issues in Medical Devices — Contributed Papers
Section on Medical Devices and Diagnostics
Chair(s): Alvin Van Orden, FDA/ CDRH
8:35 AM How Robust Are Your Trial Results? An Applied Comparison of Time-To-Event Missing Data Analyses Joshua Rapkin, Abbott
8:50 AM Bayesian Design Applications for Medical Devices Trials Using Power Prior Songtao Jiang, Boston Scientific Corporation ; Peter Lam, Boston Scientific Corporation ; Hong Wang, Boston Scientific Corporation
9:05 AM Prospective Specification of a Conditional Power Prior for Clinical Trials Tyson Rogers, NAMSA
9:20 AM Multiple Testing Approaches in Device Clinical Trials Vandana Mukhi, FDA/CDRH ; Heng Li, U. S. FDA
9:35 AM Statistical Considerations for Studies with a Performance Goal Xu Yan, U.S. Food and Drug Administration ; Heng Li, U. S. FDA ; Yun-Ling Xu, U.S. FDA
9:50 AM Benefit Risk Assessment in Medical Device Clinical Trials Mourad Atlas, FDA ; Chul Ahn, FDA
10:05 AM Learning Curve Estimation in Medical Devices and Procedures: Hierarchical Modeling Usha Govindarajulu, SUNY Downstate ; Michael Matheny, Vanderbilt University ; David Goldfarb, Montefiore Medical Center ; Marco Stillo, SUNY Downstate Medical Center ; Frederic Resnic, Lahey Clinic
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