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