Sessions Were Renumbered as of May 19.
Legend:
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
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
