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410 * Wed, 8/5/2020, 1:00 PM - 2:50 PM Virtual
Benefit-Risk Methods for Medical Devices and Diagnostics — Topic Contributed Papers
Section on Medical Devices and Diagnostics, Biopharmaceutical Section, Biometrics Section
Organizer(s): Tyson Rogers, NAMSA
Chair(s): Richard Kotz, NAMSA
1:05 PM Using Outcomes to Analyze Patients Rather Than Patients to Analyze Outcomes
Scott Evans
1:25 PM Using Patient-Centered Utility-Weighted Outcomes in a Bayesian Adaptive Enrichment Trial
Kert Viele, Berry Consultants
1:45 PM Classification Accuracy Goals for Diagnostic Tests Based on Risk Stratification
Qin Li, Food and Drug Administration; Gene Pennello, Food and Drug Administration; Dandan Xu, Food and Drug Administration
2:05 PM Discussant: Telba Irony, CBER – FDA
2:25 PM Discussant: Gregory Campbell, GCStat Consulting
2:45 PM Floor Discussion