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Design of Dose-response Clinical Trials

Thursday, March 17, 2016 - 11:00
Naitee Ting, Boehringer-Ingelheim Pharmaceuticals, ASA Fellow
Seminar
Room 4192, Earth Sciences Building, 2207 Main Mall

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
   (1976, Forestry).

   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).

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   Naitee Ting, Ph.D.
   Biostatistics
   Boehringer Ingelheim Pharmaceuticals, Inc.
   Ridgefield, Connecticut
   P: 203 798 4999

   naitee.ting [at] boehringer-ingelheim.com

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