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298 * ! Wed, 8/5/2020, 10:00 AM - 11:50 AM Virtual
Confirmatory Adaptive Designs in Action: Recent Advances in Statistical Frameworks and Operational Models — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Yihua Gu, Data and Statistical Sciences, AbbVie
Chair(s): Tianyu Zhan, AbbVie
10:05 AM Accelerating Drug Development with Adaptive Clinical Trial Designs – What Have We Learned?
Ivan Chan, AbbVie Inc
10:25 AM A Fresh View of the Efficiency of Sample Size Adaptive Designs
Lu Cui, UCB Biosciences
10:45 AM Group-Sequential Design Strategies for Testing Co-Primary Endpoints in Clinical Trials
Toshimitsu Hamasaki, George Washington University; Koko Asakura, National Cerebral and Cardiovasculer Center; Frank Bretz, Novartis Pharma AG
11:05 AM An Overview of U.S. Regulatory Considerations for Confirmatory Adaptive Design Trials
John Scott, FDA
11:25 AM Adaptive Borrowing of Historical Data in Clinical Trials
John Zhong, REGENXBIO; Peng Sun, Biogen; Charlie Cao, Biogen; Ming-Hui Chen, UNIVERSITY OF CONNECTICUT; Bo Lu, The Ohio State University; Yingying Liu, Biogen; Richard Foster, Biogen; Susie Sinks, Biogen; Fan Wu, Biogen; Giulia Gambino, Biogen
11:45 AM Floor Discussion