American Statistical Association
New York City
Metropolitan Area Chapter

Mailman School of Public Health
Columbia University
Department of Biostatistics Colloquium



CONTROVERSIAL ISSUES IN CLINICAL TRIALS

by

Shein-Chung Chow, Ph.D.
Biostatistics and Informatics
Duke University School of Medicine
www.biostat.duke.edu/modules/dukefaculty/viewDetails.php?d=chow0005&t=1


Abstract

In clinical development, clinical trials are usually conducted to collect data for evaluation of the efficacy and safety of test treatments under investigation. To provide accurate and reliable assessment, well-controlled clinical trials are necessarily conducted. Clinical trial process is a lengthy and costly process, which is necessary to ensure a fair and reliable assessment of the test treatment under investigation. Clinical trial process consists of protocol development, trial conduct, data collection, statistical analysis and reporting. In practice, however, some controversial issues are commonly encountered regardless the compliance of good clinical practice. These issues include, but are not limited to, (1) appropriate of hypotheses for drug evaluation, (2) the instability of classical sample size calculation, (3) integrity of randomization/blinding, (4) clinical strategy for endpoint selection, (5) impact of protocol amendments, (6) issue of multiplicity in clinical trials, (7) feasibility of adaptive design methods, (8) independence of data monitoring committee (DMC), (9) probability of success of clinical development, and (10) other commonly encountered controversial issues. In this presentation, these issues will be discussed. Recommendations regarding the resolutions of these issues are provided whenever possible.

Biographical Note

Shein-Chung Chow, Ph.D. is a Professor at the Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina, and a Professor at Clinical Sciences, Duke-NUS Graduate Medical School in Singapore. 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 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; Senior Statistician and Research Statistician at Parke-Davis Pharmaceutical Division, Warner-Lambert Company, Ann Arbor, MI and Wyeth-Ayerst Laboratories, Rouses Point, NY. His professional activities include serving as program chair, moderator, panelist and instructor/faculty at many professional conferences, symposia, workshops, tutorials and short courses. He is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics. 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 the recipient of the DIA Outstanding Service Award (1996), ICSA Extraordinary Achievement Award (1996), and Chapter Service Recognition Award of the American Statistical Association (1998). Dr. Chow was appointed Scientific Advisor to the Department of Health, Taiwan in 1999-2001 and 2006-date. Dr. Chow was President of the International Chinese Statistical Association, Chair of the Advisory Committee on Chinese Pharmaceutical Affairs, and a member of the Advisory Committee on Statistics of the DIA.

Dr. Chow is the author or co-author of close to 200 methodology papers and 16 books, which include Advanced Linear Models, Design and Analysis of Bioavailability and Bioequivalence Studies (1st, 2nd, and 3rd editions), Statistical Design and Analysis in Pharmaceutical Science, Design and Analysis of Clinical Trials (1st and 2nd editions), Design and Analysis of Animal Studies in Pharmaceutical Development, Encyclopedia of Biopharmaceutical Statistics (1st and 2nd editions), Sample Size Calculations in Clinical Research, Adaptive Design Methods in Clinical Trials, Statistical Design and Analysis of Stability Studies, and Translational Medicine Strategies and Statistical Methods. Dr. Chow just completed two book projects on Adaptive Design Handbook and the third edition of Encyclopedia of Biopharmaceutical Statistics, which will be published in June this year. In addition, Dr. Chow is working on two book projects: one is for controversial issues in clinical trials and the other one is for eDC in Clinical trials.

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.


Date: Thursday, March 18, 2010
Time: 4:00 - 5:00 P.M.
Location: Mailman School of Public Health
Department of Biostatistics
722 West 168th Street
Biostatistics Computer Lab
6th Floor - Room 656
New York, New York

RESERVATIONS ARE NOT REQUIRED

Informal tea at 3:40 P.M.


Home Page | Chapter News | Chapter Officers | Chapter Events
Other Metro Area Events | ASA National Home Page | Links To Other Websites
NYC ASA Chapter Constitution | NYC ASA Chapter By-Laws

Page last modified on March 18, 2010

Copyright © 1998-2010 by New York City Metropolitan Area Chapter of the ASA
Designed and maintained by Cynthia Scherer
Send questions or comments to nycasa@mindspring.com