JSM 2011 Online Program

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Activity Details

565 * Wed, 8/3/2011, 2:00 PM - 3:50 PM CC-D235
Methods to Address Rare Events, Repeat Events, and Regulatory Requirements — Topic Contributed Papers
Biopharmaceutical Section , Biometrics Section , ENAR , Section on Health Policy Statistics , Section for Statistical Programmers and Analysts , Scientific and Public Affairs Advisory Committee
Organizer(s): Jin Wang, Abbott Vascular, Yu Audrey Zhao, U.S. Food and Drug Administration/CDRH
Chair(s): Theodore Lystig, Medtronic Inc.
2:05 PM Comparison of Generalized Models for Analysis of Standardized Incidence Rates of Recurrent Events John C Evans, Boston Scientific Corporation ; Vivek Pradhan, Boston Scientific Corporation ; Jian Huang, Boston Scientific Corporation ; Wen Ding, Boston Scientific Corporation
2:25 PM Issues and Some Analysis Methods on Composite Endpoints Nelson Lu, U.S. Food and Drug Administration/CDRH ; Rajesh Nair, U.S. Food and Drug Administration/CDRH ; Chenguang Wang, U.S. Food and Drug Administration/CDRH ; Yunling Xu, U.S. Food and Drug Administration/CDRH
2:45 PM A Sensitivity Analysis of Repeat Revascularization Causal Effect on Mortality and Morbidity in Drug Eluting Stent Clinical Trials Jian Huang, Boston Scientific Corporation
3:05 PM Assessment of Safety Performance Goal Related to Rare-Event Meta-Analysis in Medical Device Studies Hsini Terry Liao, Boston Scientific Corporation
3:25 PM An Adaptive Strategy in a Single-Arm Trial Against an Objective Performance Criterion Using an Exact Test Through the Binomial Distribution — Jin Wang, Abbott Vascular ; Xiaolu Su, Abbott Vascular
3:45 PM Floor Discussion

2011 JSM Online Program Home

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