STATISTICAL DESIGN MONITORING AND ANALYSIS OF CLINICAL TRIALS PRINCIPLES AND METHODS 2ED (HB 2022) Paperback

The Second Edition of "Statistical Design, Monitoring, and Analysis of Clinical Trials" focuses on the biostatistical aspects of clinical trials. This updated version includes five new chapters and has been revised throughout. Drawing on the authors' two decades of teaching experience to public health and medical students, residents, and fellows, the book demonstrates how biostatistics in clinical trials combines fundamental scientific principles with various statistical methods. It starts by covering ethical and safety guidelines, essential trial design ideas, the principles and methods for calculating sample size and statistical power, and the analysis of covariance and stratified analysis. The text then delves into sequential designs, ranging from two-stage Phase II cancer trials to Phase III group sequential trials, including how to monitor for safety, futility, and efficacy. The authors also discuss advancements like sample size reestimation and adaptive group sequential methods, seamless Phase 2/3 designs and trials using predictive biomarkers. Furthermore, it explores multiple testing procedures and explains the concept of estimands, intercurrent events, different types of missing data, and appropriate multiple imputation techniques for analyzing incomplete data. Reflecting academic research, commercial development, and public health considerations in clinical trials, this book provides students and professionals with a multidisciplinary understanding of the concepts and techniques involved in designing, monitoring, and analyzing diverse trial types. The balanced homework assignments and in-class exercises are suitable for students and researchers in (bio)statistics, epidemiology, medicine, pharmacy, and public health.