American Statistical Association New York City Metropolitan Area Chapter Mailman School of Public Health Columbia University Department of Biostatistics Colloquium

Conventional clinical trial designs are frequently challenged regarding the ability to answer many study questions in the presence of unpredictable statistical uncertainties. The recent advances in clinical trial methodology range from a new look of group sequential design, sample size re-estimation to a mid-term change of statistical decision tree, based on interim information obtained from the internal or external data. This presentation will cover complexity of sample size planning, sample size re-estimation, adaptive selection design, issues with hierarchical testing for secondary endpoints in adaptive design trials, and logistics issues needing resolution. Some regulatory experiences will be shared.

Dr. H.M. James Hung is Director of Division of Biometrics I, Office of Biostatistics, Office of Translational Sciences Center for Drug Evaluation and Research, US FDA. The division provides services for the Division of Cardiovascular and Renal Products, Division of Neurology Products and Division of Psychiatry Products. During his 20+ year tenure with FDA, he reviewed many large mortality/morbidity clinical trials in cardiovascular and renal disease areas. He published articles in Biometrics, Statistics in Medicine, Controlled Clinical Trials, Biometrical Journal, and the Journal of Biopharmaceutical Statistics. His research areas include factorial design clinical trials, utility of p-value distribution, adaptive design/analysis in clinical trials, and non-inferiority trials, multi-regional clinical trials. Dr. Hung received two FDA/CDER Scientific Achievement Awards and many other awards for the recognition of his scientific contributions to the US FDA. He gave many invited talks, lectures or short courses in the United States, France, Germany, United Kingdom, Japan, China, and Taiwan. Currently, he serves as an Editor-in-Chief for the Journal of Pharmaceutical Statistics and an Associate Editor for Statistics in Medicine.