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Sessions Were Renumbered as of May 19.

CC-W = McCormick Place Convention Center, West Building,   CC-N = McCormick Place Convention Center, North Building
H = Hilton Chicago,   UC= Conference Chicago at University Center
* = applied session       ! = JSM meeting theme

Activity Details

44 Sun, 7/31/2016, 2:00 PM - 3:50 PM CC-W194a
Trial Design and Analysis Issues in Medical Devices — Contributed Papers
Section on Medical Devices and Diagnostics , Biopharmaceutical Section
Chair(s): Zengri Wang, Medtronic
2:05 PM Analysis of Matched Data for Noninferiority Trials Jeremiah Perez, Boston University ; Joseph M. Massaro, Boston University
2:20 PM A Constancy-Enforced Noninferiority Design of Medical Device Trials with a Binary Endpoint Ying Yang, FDA/CDRH ; Yunling Xu, FDA/CDRH ; Nelson LU, FDA/CDRH ; Yu Zhao, FDA
2:35 PM Incorporation of Historical Information in Bayesian Analysis of Crossover Medical Device Clinical Trials Youssef Toubouti, Johnson & Johnson Vision Care ; Xiwei Chen, Johnson & Johnson Vision Care
2:50 PM On Weighted Performance Goals in Medical Device Single-Arm Clinical Studies Nelson LU, FDA/CDRH ; Yunling Xu, FDA/CDRH
3:05 PM Developing and Validating Visual Assessment Tools for Use in Medical Device Trials Alvin Van Orden, FDA
3:20 PM Tests for Interaction in Clinical Studies Chul Ahn, FDA/CDRH ; Mourad Atlas, FDA/CDRH
3:35 PM Statistical Study Design Considerations for Medical Device Clinical Studies from an FDA Reviewer's Perspective Xu Yan, FDA ; Heng Li, FDA ; Vandana Mukhi, FDA
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