December 4-8, 2017 at Atlantic City, New Jersey
The 73rd Deming Conference on Applied Statistics
Sponsored by Metropolitan Section, ASQ and Biopharmaceutical Section, ASA

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12/7/2016 (Wednesday) 1:30 PM - 4:30 PM

Session L: Quantitative methods for traditional chinese medicine development

Prof. Shein-Chung Chow, Duke University School of Medicine

Moderator: Naitee Ting
In recent years, the use of complementary and alternative medicine including botanical drug product and traditional Chinese (herbal) medicine (TCM) in humans for treating critical and/or life-threatening diseases has received much attention. In pharmaceutical/clinical development of a given TCM, one of the major criticisms is lack of objectively scientific evidence (documents) of clinical safety and efficacy. Unlike the Western medicines (WM), TCM often consists of multiple components (active ingredients) whose pharmacological activities are often unknown or are not fully characterized or understood. Thus, standard methods for WM clinical trials may not be appropriately applied directly to TCM clinical trials. In this tutorial, some statistical considerations including selection of study design, preparation of matching placebo, development of study endpoint, validation of an instrument, calibration of the validated instrument, and power calculation for sample size estimation are discussed. These considerations have an impact on effectively and scientifically evaluation of clinical safety and efficacy of TCM in clinical trials. In addition, some practical issues regarding test for consistency in raw materials, stability of drug substance, and animal studies are also discussed.

Shein-Chung Chow, Ph.D. is currently a Professor at the Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, and an Adjunct Professor at Duke-NUS, Singapore and North Carolina State University, Raleigh, NC. Dr. Chow is also the Founding Director of the Global Clinical Trial and Research Center, Tianjin, China. Prior to joining Duke University, he was the Director of TCOG (Taiwan Cooperative Oncology Group) Statistical Center and the Executive Director of National Clinical Trial Network Coordination Center. Prior to that, Dr. Chow also held various positions in the pharmaceutical industry such as Vice President, Biostatistics, Data Management, and Medical Writing at Millennium Pharmaceuticals, Inc., Cambridge, MA; Executive Director, Statistics and Clinical Programming at Covance, Inc., Director and Department Head at Bristol-Myers Squibb Company, Plainsboro, NJ. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics, Open Access Drug Designing, and the Journal of Biosimilars. Dr. Chow is also the Editor-in-Chief of the Biostatistics Book Series at Chapman and Hall/CRC Press of Taylor & Francis Group. He was elected Fellow of the American Statistical Association in 1995 and an elected member of the ISI (International Statistical Institute) in 1999. He was recently appointed as an Advisory Committee member and consultant to the FDA by the FDA. Dr. Chow is the author or co-author of over 280 methodology papers and 24 books including Design and Analysis of Bioavailability and Bioequivalence Studies, Statistical Design and Analysis in Pharmaceutical Science, Design and Analysis of Clinical Trials, Design and Analysis of Animal Studies in Pharmaceutical Development, Sample Size Calculations in Clinical Research, Adaptive Design Methods in Clinical Trials, Translational Medicine, Design and Analysis of Bridging Studies, Biosimilars: Design and Analysis of Follow-on Biologics., and Quantitative Methods for Traditional Chinese Medicine Development.

Dr. Chow received a B.S. in mathematics from National Taiwan University, Taiwan, and a Ph.D. in statistics from the University of Wisconsin, Madison, Wisconsin.

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