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* = applied session ! = JSM meeting theme
Activity Details
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153 * !
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Tue, 8/4/2020,
10:00 AM -
11:50 AM
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Virtual
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Utilization of Historical Data for Confirmatory Trials — Topic Contributed Papers
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Biopharmaceutical Section, Health Policy Statistics Section, Society for Clinical Trials
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Organizer(s): Freda Cooner, Amgen Inc.
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Chair(s): Freda Cooner, Amgen Inc.
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10:05 AM
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Use of Historical Data in Regulatory Applications – Advantages and Challenges
Shiowjen Lee, FDA/CBER/OBE/DB
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10:25 AM
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Statistical Considerations for Borrowing Historical Data in Small Populations
Fanni Natanegara, Eli Lilly and Company
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10:45 AM
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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
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11:05 AM
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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
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11:25 AM
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Discussant: Haijun Ma, NeKtar Therapeutics
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11:45 AM
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Floor Discussion
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