Challenges in designing these studies include: selection of the dose
frequency and the dose range, choice of clinical endpoints or biomarkers,
and use of control(s), among others. Consequences of bad Phase II study
designs may lead to the delay of the entire clinical development program
or the waste of R&D investment. Misleading results obtained from poor
designs could cause a Phase III program to confirm a wrong set of doses,
or to stop developing a potentially useful drug. Therefore, it is
critical to consider an entire drug development plan, to make best use of
all the available information, and to include all relevant experts in
designing Phase II dose response clinical trials. This presentation
discusses some of these considerations.
Biography of Speaker
Naitee Ting is a Fellow of ASA. He is currently a Sr. Principal
Biostatistician in the Biometrics Department of Boehringer-Ingelheim
Pharmaceuticals Inc. (BI). He joined BI in September of 2009, and before
joining BI, he was at Pfizer Inc. for 22 years (1987-2009). Naitee
received his Ph.D. in 1987 from Colorado State University (major in
Statistics). He has an M.S. degree from Mississippi State University
(1979, Statistics) and a B.S. degree from College of Chinese Culture
Naitee published articles in Technometrics, Statistics in Medicine, Drug
Information Journal, Journal of Statistical Planning and Inference,
Journal of Biopharmaceutical Statistics, Biometrical Journal, Statistics
and Probability Letters, and Journal of Statistical Computation and
Simulation. His book Dose Finding in Drug Development was published in
2006 by Springer. The book Fundamental Concepts for New Clinical
Trialists, co-authored with Scott Evans, was published by CRC in 2015.
Naitee is an adjunct professor of Columbia University, University of
Connecticut and University of Rhode Island. Naitee has been an active
member of both the American Statistical Association (ASA) and the
International Chinese Statistical Association (ICSA).
Naitee Ting, Ph.D.
Boehringer Ingelheim Pharmaceuticals, Inc.
P: 203 798 4999
naitee.ting [at] boehringer-ingelheim.com
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