Title : Practical and Challenging Statistical Issues in Regulatory Science
Professor Shein-Chung Chow, Duke University
Naitee Ting



This invited talk will focus on the recent advances on the following topics pertinent to cardio-renal trials and CNS trials.

  1. Hazard ratio, restrictive mean survival time, win ratio
  2. Innovative clinical trial designs
  3. Statistical inferences for multiple endpoints
  4. Recurrent events
  5. Estimands
  6. Reasonably likely predictive

Speaker Bio:

Dr. H.M. James Hung is presently Director of Division of Biometrics I, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). The Division provides statistical services supporting Division of Cardiovascular and Renal Products, Division of Neurology Products, Division of Psychiatry Products, and Division of Medical Imaging Products, CDER, FDA.

During his tenure with FDA, Dr. Hung has reviewed many large mortality/morbidity clinical trials in cardiovascular and renal disease areas. He published many peer reviewed articles in Biometrics, Statistics in Medicine, Controlled Clinical Trials, Biometrical Journal, Journal of Biopharmaceutical Statistics, and Pharmaceutical Statistics. His research areas include multi-regional clinical trials, adaptive design/analysis, non-inferiority trials, factorial design clinical trials, and utility of p-value distribution. He delivered a great many of invited talks, lectures or short courses in many countries.

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 is the recipient of 2011 FDA Scientific Achievement Award – Excellence of Analytic Science. He also received awards for recognizing his contributions to the FDA guidance documents on adaptive designs and non-inferiority trial designs.

Dr. Hung served as an Editor-in-Chief for Journal of Pharmaceutical Statistics in 2009-2011. Currently, he serves as an Associate Editor for Statistics in Medicine. He is a Fellow of the American Statistical Association and an elected member of the International Statistical Institute.

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