Strategy and Statistics in Clinical Trials

Strategy and Statistics in Clinical Trials deals with the research processes and the role of statistics in these processes. The book offers real-life case studies and provides a practical, how to guide to biomedical R&D. It describes the statistical building blocks and concepts of clinical trials and promotes effective cooperation between statisticians and important other parties. The discussion is organized around 15 chapters. After providing an overview of clinical development and statistics, the book explores questions when planning clinical trials, along with the attributes of medical products. It then explains how to set research objectives and goes on to consider statistical thinking, estimation, testing procedures, and statistical significance, explanation and prediction. The rest of the book focuses on exploratory and confirmatory clinical trials; hypothesis testing and multiplicity; elements of clinical trial design; choosing trial endpoints; and determination of sample size. This book is for all individuals engaged in clinical research who are interested in a better understanding of statistics, including professional clinical researchers, professors, physicians, and researchers in laboratory. It will also be of interest to corporate and government laboratories, clinical research nurses, members of the allied health professions, and post-doctoral and graduate students.