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ON DEMAND - Best Practices for Randomization and Re-Randomization in Clinical Trials
Session Chair(s)
Yeh-Fong Chen, PhD
Mathematical Statistician (Team Lead), Office of Translational Sciences, CDER
United States
Randomized clinical trials (RCT) are traditionally conducted in the context of demonstrating the efficacy and safety of medical products. Although RCT can effectively avoid confounding and are the gold standard, trial designers and analysts are not always trained on how to plan and implement randomization properly. In light of the increasing popularity of adaptive and enrichment designs with multiple stages, where updating the randomization ratio or re-randomizing the same or new patients is possible, it is important to monitor its practice and impact on ongoing trials. While Bayesian approaches (e.g., response-dependent randomization) in such designs have been increasingly considered, their perceived advantage or disadvantage over traditional frequentist approaches warrants more research. In this session, speakers from the industry, academia, and regulatory agencies are invited to discuss their research and viewpoints and share practical experiences.
Learning Objective : Recognize and achieve proper implementation of randomization, with the update of randomization ratio during a trial with multiple stages.
Speaker(s)
Best Practices for Randomization: Pros and Cons of Minimization
Linda L. Danielson, MS
IDDI Inc, United States
Chief Operating Officer and Executive Vice President
Clinical Trials with Multiple Randomization Schedules: Rationale and Implementation
Roy Tamura, PhD
University of South Florida, United States
Associate Professor of Biostatistics
FDA Update
H. M. James Hung, PhD
FDA, United States
Director, Division of Biometrics I, Office of Biostatistics, OTS, CDER
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