Sessions Were Renumbered as of May 19.
Legend:
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
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
