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Sessions Were Renumbered as of May 19.

CC-W = McCormick Place Convention Center, West Building,   CC-N = McCormick Place Convention Center, North Building
H = Hilton Chicago,   UC= Conference Chicago at University Center
* = applied session       ! = JSM meeting theme

Activity Details

646 * Thu, 8/4/2016, 8:30 AM - 10:20 AM CC-W187c
Multiplicity in Diagnostic Device Development and Validation — Topic Contributed Papers
Section on Medical Devices and Diagnostics , Biopharmaceutical Section , Section on Statistics in Imaging
Organizer(s): Gene Pennello, FDA/CDRH/OSB/DBS
Chair(s): Alicia Y. Toledano, Biostatistics Consulting, LLC
8:35 AM Identifying Optimal Approaches to Early Termination in Two-Stage Biomarker Validation Studies Alexander Kaizer, University of Minnesota ; Joseph S. Koopmeiners, University of Minnesota
8:55 AM Statistical Considerations in Evaluating Radiological Imaging Devices in FDA/CDRH Qin Li, FDA/CDRH
9:15 AM Different Success Criteria in the Performance Evaluation of Diagnostic Devices Norberto Pantoja-Galicia, FDA/CDRH ; Gene Pennello, FDA/CDRH/OSB/DBS
9:35 AM Creating a Biomarker Signature for a Companion Diagnostic Using Bootstrapping and Aggregating Thresholds from Tree-Based Models Raj Chandran
9:55 AM Multiple Endpoint Evaluation in Diagnostic Medical Imaging: Analyses, Labeling, and Claims Camille Vidal, GE Healthcare
10:15 AM Floor Discussion
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