Model-Assisted Bayesian Designs for Dose Finding and Optimization

This book shows how model-assisted designs can greatly improve the efficiency and simplify the conduct of early-phase dose finding and optimization trials. It should therefore be a very useful practical reference for biostatisticians, clinicians working in clinical trials, and drug regulatory professionals, as well as grad students.

Auteur

Ying Yuan, Ph.D., is Bettyann Asche Murray Distinguished Professor in Biostatistics and Deputy Chair at the Department of Biostatistics at the University of Texas MD Anderson Cancer Center. He has published over 100 statistical methodology papers on innovative Bayesian adaptive designs, including early phase trials, seamless trials, biomarker-guided trials, and basket and platform trials. The designs and software developed by Dr. Yuan's and Dr. J. Jack Lee's team (www.trialdesign.org) have been widely used in medical research institutes and pharmaceutical companies. The BOIN design developed by Dr. Yuan's team is the first oncology dose-finding design designated as a fit-for-purpose drug development tool by FDA. Dr. Yuan is an elected Fellow of the American Statistical Association, and is a co-author of the book Bayesian Designs for Phase I-II Clinical Trials published by Chapman & Hall/CRC Press.

Ruitao Lin, Ph.D., is an Assistant Professor in the Department of Biostatistics at the University of Texas MD Anderson Cancer Center. Motivated by the unmet need for the development of precision medicine, Dr. Lin has developed many innovative statistical designs to increase trial efficiency, optimize healthcare decisions, and expedite drug development. He made substantial contributions to generalize model-assisted designs, including BOIN, to handle combination trials, late-onset toxicity, and dose optimization. Dr. Lin has published over 40 papers in top statistical and medical journals. He currently is an Associate Editor of Biometrial Journal, Pharmaceutical Statistics, and Contemporary Clinical Trials.

J. Jack Lee, Ph.D., is a Professor of Biostatistics, Kenedy Foundation Chair in Cancer Research, and Associate Vice President in Quantitative Sciences at the University of Texas MD Anderson Cancer Center. He is an expert on the design and analysis of Bayesian adaptive designs, platform trials, basket trials, umbrella trials, master protocols, statistical computation/graphics, drug combination studies, and biomarkers identification and validation. Dr. Lee has also been actively participating in basic, translational, and clinical cancer research in chemoprevention, immuno-oncology, and precision oncology. He is an elected Fellow of the American Statistical Association, the Society for Clinical Trials, and the American Association for the Advancement of Science. He is Statistical Editor of Cancer Prevention Research and serves on the Statistical Editorial Board of Journal of the National Cancer Institute. He has over 500 publications and is a co-author of the book Bayesian Adaptive Methods for Clinical Trials published by Chapman & Hall/CRC Press.