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