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121 * ! | Mon, 8/10/2015, 8:30 AM - 10:20 AM | CC-612 | |
Minimizing Bias in Medical Device Trials Through Study Design and Data Analysis — Topic Contributed Papers | |||
Section on Medical Devices and Diagnostics , Government Statistics Section , Biometrics Section | |||
Organizer(s): Laura Lu, FDA/CDRH, Jack Zhou, FDA/CDRH | |||
Chair(s): Laura Lu, FDA/CDRH | |||
8:35 AM | Study Design Using Bayesian Conditional Borrowing of the Prior with Multiple Cutoffs — Peter Lam, Boston Scientific ; Songtao Jiang, Boston Scientific ; Ming-Hui Chen, University of Connecticut | ||
8:55 AM | Sensitivity Analysis for Clinical Trials with Missing Outcome Data Using Repeated Measures: A Simulation Study Design — Terry Liao, Boston Scientific ; Ying Yang, FDA | ||
9:15 AM | Minimizing Bias in Observational Comparative Clinical Studies — Lilly Yue, FDA/CDRH | ||
9:35 AM | Practical Considerations for Establishing Monitoring Committees in Device Trials for Ensuring Trial Validity — Rajesh Nair, CDRH/FDA | ||
9:55 AM | Floor Discussion |
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