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153 * ! Tue, 8/4/2020, 10:00 AM - 11:50 AM Virtual
Utilization of Historical Data for Confirmatory Trials — Topic Contributed Papers
Biopharmaceutical Section, Health Policy Statistics Section, Society for Clinical Trials
Organizer(s): Freda Cooner, Amgen Inc.
Chair(s): Freda Cooner, Amgen Inc.
10:05 AM Use of Historical Data in Regulatory Applications – Advantages and Challenges
Shiowjen Lee, FDA/CBER/OBE/DB
10:25 AM Statistical Considerations for Borrowing Historical Data in Small Populations
Fanni Natanegara, Eli Lilly and Company
10:45 AM Historical Data Borrowing with Informative Inferential Prior for Bayesian Hypothesis Testing
Hui Quan, Sanofi; Bingzhi Zhang, Sanofi; Yu Lan, Sanofi; Xiaodong Luo, Sanofi; Xun Chen, Sanofi
11:05 AM Improving Clinical Trial Efficiency Using Natural History Study Data and Innovative Trial Design
Barbara Wendelberger, Berry Consultants, LLC; Melanie Quintana, Berry Consultants; Scott Berry, Berry Consultants
11:25 AM Discussant: Haijun Ma, NeKtar Therapeutics
11:45 AM Floor Discussion