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Activity Details

297 * Tue, 8/5/2014, 8:30 AM - 10:20 AM CC-157B
Design and Analysis of Therapeutic Medical Device Trials — Contributed Papers
Section on Medical Devices and Diagnostics , Section on Physical and Engineering Sciences
Chair(s): Roseann White, Abbott   
8:35 AM A Score Test for Detecting Heterogeneous Within-Group Variances in Linear Mixed Models Chul Ahn, FDA-CDRH ; Nelson Lu, FDA/CDRH
8:50 AM Practical Issues with Designing and Executing Bayesian Adaptive Medical Device Trials Rajesh Nair ; Nelson Lu, FDA/CDRH ; Xiting Yang, FDA
9:05 AM Incorporation of Prior Information in a Clinical Trial Manuela Buzoianu, FDA
9:20 AM Dichotomizing Non-Normal Continuous Data While Retaining Statistical Precision for Informing a Commensurate Prior Byron Gajewski, University of Kansas Medical Center ; C. Shane Reese, Brigham Young University ; John A. Colombo, University of Kansas ; Susan E. Carlson, University of Kansas Medical Center
9:35 AM Practical Issues on the Observational Comparative Study Design Using Propensity Score Methodology in Pre-Market Medical Device Clinical Studies from the Regulatory Perspectives Nelson Lu, FDA/CDRH ; Lilly Yue, FDA/CDRH ; Yunling Xu, FDA/CDRH
9:50 AM Sensitivity Analysis for Clinical Trials with Missing Outcome Data: a Bayesian Tipping Point Analysis Ying Yang, FDA/CDRH ; Yu Zhao, FDA ; Meichun Ding, GlaxoSmithKline
10:05 AM Simulation Exercise in Days Alive and Out of Hospital (DAOH) Endpoint Peter Lam, Boston Scientific ; Songtao Jiang, Boston Scientific ; Jian Huang, Medtronic

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