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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)
Incorporating Adult Study Data into Pediatric Clinical Trials: Is Bayesian Borrowing the Solution?
James Travis, PhD
FDA, United States
Lead Mathematical Statistician, OB, OTS, CDER
Approaches to Medical Device Evaluation Using Real-World Evidence
Sharon-Lise Normand, PhD
Harvard Medical School, United States
Professor of Health Care Policy (Biostatistics)
Bayesian Applications for Extrapolation from Adult to Pediatric Data
Amy Xia, PhD
Amgen Inc., United States
Vice President, Center for Design and Analysis
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