Component Type: Session
Level: Intermediate

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 Objectives

Recognize and achieve proper implementation of randomization, with the update of randomization ratio during a trial with multiple stages.

Chair

Yeh-Fong Chen, PhD

Speaker

Best Practices for Randomization: Pros and Cons of Minimization
Linda L. Danielson, MS

Clinical Trials with Multiple Randomization Schedules: Rationale and Implementation
Roy Tamura, PhD

FDA Update
H. M. James Hung, PhD