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Activity Details

382 Tue, 8/1/2017, 2:00 PM - 3:50 PM CC-308
Improving the Efficiency of Medical Device Clinical Trials by Combining Simulations and Experiments — Invited Papers
Section on Medical Devices and Diagnostics , Biopharmaceutical Section , Society for Medical Decision Making
Organizer(s): Rajesh Nair, FDA/CDRH/OSB/DBS
Chair(s): Tarek Haddad, Medtronic Cardiac Rhythm and Heart Failure
2:05 PM The Past Is Prologue: The Use of Prior Information and Bayesian Methodologies in Designing Medical Device Regulatory Approval Trial Roseann White, Pragmatic clinical trial Statistics, Duke Clinical Research Institute
2:20 PM Incorporation of Stochastic Engineering Models as Prior Information in Bayesian Medical Device Trials Valentin Parvu, BDX Corporate/Shared services, BD
2:35 PM Discussant: Telba Irony, Office of Biostatistics and Epidemiology, CBER, FDA
2:50 PM Discussant: Kyle Myers, Office of Science and Engineering Laboratories, CDRH
3:05 PM Discussant: Scott Evans, Harvard University
3:20 PM Discussant: Greg Campbell, GC stat consulting and former Director DBS/CDRH
3:35 PM Floor Discussion
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