The authors present the essence of statistical reasoning in clinical trials,peppered with well-known clinical trials This book uses only a small number of important principles to develop the entire statistical foundation of clinical trials.

Michael Proschan is a mathematical statistician and Fellow of the American Statistical Association with 32 years of clinical trial experience in cardiovascular and infectious diseases, including HIV/AIDS, Ebola virus disease, and COVID-19. He has expertise in statistical monitoring of clinical trials, having taught short courses and co-authored the book Statistical Monitoring of Clinical Trials: A Unified Approach with Gordon Lan and Janet Wittes. He co-authored, with Sally Hunsberger, one of the first papers on adaptive clinical trial methods using the observed treatment effect at an interim analysis. More recently, Dr. Proschan has written about the vital role re-randomization tests play in adaptive methods before breaking the treatment blind. He has recently been an adjunct faculty member at George Washington University and Johns Hopkins University's Advanced Academic Programs.

1. Evidence and Inference. 2. 2 × 2 Tables. 3. Introduction to Clinical Trials. 4. Design of Clinical Trials. 5. Randomization/Allocation. 6. Randomization-Based Inference7 Survival Analysis. 7. Sample Size/Power. 8. Monitoring. 9. M&Ms: Multiplicity & Missing Data. 10. Adaptive Methods.