Phase II Clinical Development of New Drugs

Chapter 1 Introduction.- Chapter 2 Concept of Alpha.- Chapter 3 Confirmation and Exploration.- Chapter 4 Design a Proof of Concept (PoC) Trial.- Chapter 5 Design of Dose-Ranging Trials.- Chapter 6 Combining PoC and Dose Ranging Trials.- Chapter 7 Risks of Inconclusiveness.- Chapter 8 Analysis of a PoC Study.- Chapter 9 Data Analysis for Dose-Ranging Trials with Continuous Outcome.- Chapter 10 Data Analysis of Dose-Ranging Trials for Binary Outcomes.- Chapter 11 Bayesian Methods.- Chapter 12 Overview of Phase III Clinical Trials.

Naitee Ting is a Fellow of ASA. He is currently a Director in the Department of Biostatistics and Data Sciences at 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) 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 ofdose response clinical trials.  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).
Professor Ding-Geng Chen is a fellow of the American Statistical Association and currently the Wallace Kuralt distinguished professor at the University of North Carolina at Chapel Hill, USA, and an extraordinary professor at University of Pretoria, South Africa. He was a professor at the University of Rochester and the Karl E. Peace endowed eminent scholar chair in biostatistics at Georgia Southern University. He is also a senior consultant for biopharmaceuticals and government agencies with extensive expertise in clinical trial biostatistics and public health

"It provides a hands-on approach to each subject, and the necessary statistical background is presented in the most non-mathematical way possible. ... Throughout the book, the scope of each subject is well defined, and if the reader has the need for further support, useful references are helpfully recommended. ... I would strongly recommend this book to anyone working in clinical development or with an interest in this field, regardless of their background." (David Manteigas, ISCB News, iscb.info, Issue 65, June, 2018)