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A * preceding a session name means that the session is an applied session.
A ! preceding a session name means that the session reflects the JSM meeting theme.
A * preceding a session name means that the session is an applied session.
A ! preceding a session name means that the session reflects the JSM meeting theme.
Activity Details
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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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