Sequential Experimentation in Clinical Trials

Introduction.- Nonlinear Regression, Experimental Design, and Phase I Clinical Trials.- Sequential Testing Theory and Stochastic Optimization over Time.- Group Sequential Design of Phase II and III Trials.- Sequential Methods for Vaccine Safety Evaluation and Surveillance in Public Health.- Time-Sequential Design of Clinical Trials with Failure-Time Endpoints.- Confidence Intervals and p-Values.- Adaptive Design of Confirmatory Trials.- References.

Jay Bartroff is Associate Professor of Mathematics at the University of Southern California where he is a member of the Laboratory of Applied Pharmacokinetics at the USC Keck School of Medicine. He is a leading expert on group sequential and multistage adaptive statistical procedures and their applications to clinical trial designs, and he is a sought-after consultant in academia and industry. Tze Leung Lai is Professor of Statistics, and by courtesy, of Health Research and Policy and of the Institute of Computational and Mathematical Engineering at Stanford University, where he is the Director of the Financial and Risk Modeling Institute and Co-director of the Biostatistics Core at the Stanford Cancer Institute and of the Center for Innovative Study Design at the School of Medicine. He made seminal contributions to sequential analysis, innovative clinical trial designs, adaptive methods, survival analysis, nonlinear and generalized mixed models, hybrid resampling methods, and received the Committee of Presidents of Statistical Societies (COPSS) Award in 1983. Mei-Chiung Shih is Assistant Professor of Biostatistics and a member of the Stanford Cancer Institute and of the Center for Innovative Study Design at the School of Medicine at Stanford University. She is also Associate Director for Scientific and Technical Operations at the Department of Veterans Affairs (VA) Cooperative Studies Program Coordinating Center at Palo Alto Health Care System. She is a leading expert on group sequential and adaptive designs and inference of clinical trials, longitudinal and survival data analysis, and has been leading the design, conduct and analysis of several large trials at the VA.

"This outstanding book written by three prominent scholars present in depth sequential designs and analyses for different clinical trials. ... The book can also be used for short courses on clinical trials, translational medical research, and sequential experimentation by selecting the relevant parts of it." (Subir Ghosh, Technometrics, Vol. 56 (4), November, 2014)"It is definitely a 'must read' for anyone doing research into the theory or methodology of modern sequential statistical analysis." (Bruce W. Turnbull, Mathematical Reviews, May, 2014)