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

Activity Details

500 * ! Wed, 8/2/2017, 10:30 AM - 12:20 PM CC-313
Beyond Randomized Studies: Nonrandomized, Single Arm, or Special Studies — Topic Contributed Papers
Section on Medical Devices and Diagnostics
Organizer(s): Shiling Ruan, Novartis, Jie (Jack) Zhou, FDA/CDRH
Chair(s): Ahn Chul, FDA/CDRH
10:35 AM Why Not Consensus Reading with Multiple Readers for Evaluating a New (Test) Device? Bipasa Biswas, CDRH, FDA
10:55 AM Confidence Interval Estimate of Success Rate on Correlated Data in a Single Arm Study Kate Wang, Allergan ; Richard Weng, Allergan ; Yijun Sun, Allergan
11:15 AM A Bayesian Approach Developed for Single Arm Studies Using Performance Goals with Subgroups Wei-Chen Chen, FDA/CDRH ; Nelson Lu, CDRH/FDA
11:35 AM Biomarker Based Study Design with Multiple Single Arms Shiling Ruan, Novartis
11:55 AM Design and Analysis of Single Arm Clinical Trials Involving Highly Heterogeneous Subjects Sherry Liu, FDA
12:15 PM Floor Discussion
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