SESSION A – The Annual Deming Conference on Applied Statistics

TITLE: Clinical Drug Development: a Case Study and a Few Stories
SPEAKER: Naitee Ting, StatsVita
Moderator: Din Chen

Abstract:

The case study is about the development of an anti-inflammatory agent. Pain management has long been a medical challenge. Chronic pain tends to be the pain that lasts more than three months. Depending on source of pain, it can be classified as neuropathic pain, inflammatory pain, cancer pain, and others. This tutorial includes a case study of developing a new drug for the management of inflammatory pain. The drug was discovered in the 1980’s. It was developed for three indications – acute pain (use of a dental pain model), osteoarthritis (OA), and rheumatoid arthritis (RA). This drug has clear efficacy in all three indications. Unfortunately, after over 10 years of clinical development, a late developed adverse event was considered as potentially toxic to patients. This drug was not marketed because its benefit does not outweigh the associated risks.

Instructors’ Biography:

Naitee Ting is a Fellow of American Statistical Association (ASA). He is currently Vice President of Veramed. Naitee is also an Adjunct Professor of Department of Statistics at University of Connecticut, Adjunct Professor of Department of Biostatistics at Columbia University. He joined StatsVita in October, 2024. Before StatsVita, Naitee has been with Boehringer Ingelheim Pharmaceuticals, Inc. (BI) for 15 years, and he was working 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) at Taipei, Taiwan.

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, and is considered as the leading reference in the field of dose response clinical trials. The book “Fundamental Concepts for New Clinical Trialists”, co-authored with Scott Evans, was published by CRC in 2015. Another book “Phase II Clinical Development of New Drugs”, co-authored with Chen, Ho, and Cappelleri was published in 2017 (Springer). Naitee is an adjunct professor of Columbia University, University of Connecticut, and Colorado State University. Naitee has been an active member of both the ASA and the International Chinese Statistical Association (ICSA).