Dr. Yi Tsong
Division Director for Biometrics VI
Office of Biostatistics
Office of Translational Sciences
Center for Drug Evaluation and Research, FDA
Title: Duality of significance tests and confidence intervals in drug development
Abstract: At FDA as well as industry, we promote powerful test with type I error rate controlled. It leads to various tests using different standard error or confidence interval. We often ignored that the confidence interval should be consistent with the test. It happens also often in equivalence testing when 90% confidence interval is used to decide if the two treatments are equivalent. I examined cases with normal and binary data. We will extend it to cover Poisson and survival data.
Yi Tsong received his Ph.D. in Statistics from the University of North Carolina at Chapel Hill in 1979. He did his post-doctoral training in cardiovascular prevention and biostatistics at Northwestern Medical School (1978-1980). He worked as senior statistician in pattern recognition at Lockheed Engineering and Management Company (1981-1983) and biostatistical consultant at the University of Texas Medical Branch at Galveston (1984-1987) before joining FDA. He served as team leader of postmarketing risk assessment and statistical reviewer of NDA submission of critical care and pain relief products.
He is currently the Division Director and Acting Team Leader for statistical team of Chemistry and Manufacturing Control. He specializes in postmarketing risk assessment, drug manufacturing process control and quality assurance, active control noninferiority/equivalence tests, adaptive designs and QTc trials. He received 8 CDER and 12 FDA level awards for contributions in postmarketing drug risk assessment, for advisory on CDER postmarketing risk assessment external contracts, medication errors, quality control evaluation, drug compliance, in vitro bioequivalence, drug compliance, drug abuse potential studies, setting quota of scheduled substances, adaptive design and non-inferiority tests, et al. He publishes frequently in numerous professional journals. He served as Treasurer, Board Director and President of International Chinese Statistical Association. He serves also as the Associate Editor of Statistics in Medicine and Journal of Biopharmaceutical Statistics.
