JSM 2011 Online Program

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457 *	Wed, 8/3/2011, 8:30 AM - 10:20 AM	CC-C220
Statistical Considerations for the Evaluation of Diagnostic Devices and Biomarkers — Topic Contributed Papers
Biopharmaceutical Section , Section on Health Policy Statistics , Section on Risk Analysis , Section on Statistics in Epidemiology , Scientific and Public Affairs Advisory Committee
Organizer(s): Shanti Gomatam, U.S. Food and Drug Administration/CDRH,
Chair(s): Shanti Gomatam, U.S. Food and Drug Administration/CDRH
8:35 AM	Early Detection Claim in IVD Devices: Statistical Issues and Challenges — Chunrong Cheng, U.S. Food and Drug Administration ; Tie-Hua Ng, U.S. Food and Drug Administration
8:55 AM	Prediction Biomarkers for Safety or Efficacy — Estelle Russek-Cohen, U.S. Food and Drug Administration ; Rong Tang , U.S. Food and Drug Administration
9:15 AM	Individualized Disease Diagnostics: Improving Diagnostic Tests with Genomic/Genetic/Clinical Information — Meijuan Li, U.S. Food and Drug Administration/CDRH
9:35 AM	Minimum Statistical Standards for Biomarker Development — Jae Kyun Lee, University of Virginia
9:55 AM	Discussant: Greg Campbell, U.S. Food and Drug Administration/DHHS/CDRH/OSB/DBS
10:15 AM	Floor Discussion

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