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117 * Mon, 7/30/2012, 8:30 AM - 10:20 AM CC-Room 25C
Statistical Issues in Adaptive Clinical Trial Design — Topic Contributed Papers
Biopharmaceutical Section , International Indian Statistical Association , Statistics Surveys Online Journal
Organizer(s): Min Annie Lin, FDA/CBER
Chair(s): Boguang Zhen, FDA/CBER
8:35 AM Perception and use of adaptive designs in the industry and academia: persistent barriers and recommendations to overcome challenges Alun Bedding, GlaxoSmithKline
8:55 AM Benefits, Challenges, and Obstacles of Adaptive Clinical Trial Designs Shein-Chung Chow, Duke University School of Medicine
9:15 AM Regulatory Experience: Adaptive Designs in CBER Submissions Min Annie Lin, FDA/CBER
9:35 AM Adjusting for Misclassification In Stratified Biomarker Clinical Trials Aiyi Liu, National Institute of Child Health and Human Development
9:55 AM Discussant: Estelle Russek-Cohen, FDA/CBER
10:15 AM Floor Discussion



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