JSM 2011 Online Program
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Activity Details
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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 |
2011 JSM Online Program Home
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