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Bayesian Application in Small-Sized Clinical Trials
Session Chair(s)
Fei Wang, PHD
Senior Manager, Biostatistics, Amgen, United States
The use of historical data demonstrates value and efficiency in designing clinical trials, especially in nonconfirmatory trials. This session presents an overview of theoretical framework, case studies in exploratory situations, and future directions.
Learning Objective : Describe the use of historical information on controls in rare disease and pediatric settings; Discuss the challenges and concerns in design of confirmatory trials; Analyze industry and regulatory point of view and potentially pilot solutions.
Speaker(s)
James Travis, PHD
Lead Mathematical Statistician, OB, OTS, CDER, FDA, United States
Sharon-Lise Normand, PHD
Professor of Health Care Policy (Biostatistics), Harvard Medical School, United States
Amy Xia, PHD
Vice President, Center for Design and Analysis, Amgen Inc., United States
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