Thursday, June 18 • 5:00pm - 6:00pm
#563 OD: ON DEMAND - Best Practices for Randomization and Re-Randomization in Clinical Trials

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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.


Yeh-Fong Chen, PhD


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

avatar for Yeh-Fong Chen

Yeh-Fong Chen

Mathematical Statistician (Team Lead), Office of Translational Sciences, CDER, FDA
Dr. Chen is the Team Leader of the Division of Biometrics IX within CDER of FDA, supervising reviewers for the Division of Non-Malignant Hematology Products. She joined FDA in 2000 after receiving her Ph.D. from the University of Iowa. She has had years' experience in reviewing drug... Read More →
avatar for Linda Danielson

Linda Danielson

Chief Operating Officer and Executive Vice President, IDDI Inc
Linda Danielson has been Chief Operating Officer at the International Drug Development Institute (IDDI) since 2011. Linda obtained her M.S. degree in Biostatistics in 1990 from the University of Wisconsin, Madison. She has over 25 years of experience in the Pharmaceutical Industry... Read More →

Roy Tamura

Associate Professor of Biostatistics, University of South Florida
Roy Tamura is an associate professor of biostatistics in the Health Informatics Institute at the University of South Florida. His research interests are in the areas of clinical trial design and in the statistical properties of multi-stage, re-randomization clinical trials. These... Read More →

H. M. James Hung

Director, Division of Biometrics I, Office of Biostatistics, OTS, CDER, FDA
Dr. James Hung is currently Director, Division of Biometrics I, CDER, US FDA. The division provides services for the medical divisions: Neurology, Psychiatry, Anesthesiology, Addiction Medicine, and Pain Medicine, Medical Imaging and Radiation Medicine.

Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Session