An Introduction to Clinical Trials

An Introduction to clinical trials is a concise step-by-step guide to the principles and practices of clinical trials for those studying clinical trials or new to working on one. Clinical trials are critical to the progress of medicine and improving healthcare, as they evaluate whether new treatments and interventions work. They are also complex, multidisciplinary projects that integrate science, ethics, and legal requirements in the conduct of medical research.

Starting with the research question, An Introduction to clinical trials explains study design, sample size determination, study set-up, study conduct, statistical analysis, and dissemination of the results. The book primarily focusses on randomised controlled trials as the "ultimate" clinical trial. It demystifies the terminology used in clinical trials research and presents the underlying scientific and statistical concepts. Real-life examples are used throughout to bring concepts to life.

Written by an experienced medical statistician, An Introduction to clinical trials will benefit readers of all backgrounds, from postgraduate and medical students, trainee doctors and healthcare professionals to others working on clinical trials in a professional capacity. This book aims to help readers gain a fuller and more rounded understanding of clinical trials.

Jonathan A. Cook, Associate Professor, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Institute for Musculoskeletal Sciences, Oxford, UK

Jonathan A. Cook is an experienced medical statistician. He has worked on over 30 clinical trials spanning over 20 years. He has published over 300 peer reviewed publications in leading medical journals. Jonathan's main research interest is in the design, conduct, analysis, and reporting of randomised controlled trials. He serves as a Deputy Editor for the Clinical Trials journal, and a statistical consultant for the British Journal of Surgery. He has collaborated on numerous medical research projects in a wide range of clinical areas.