Fully updated, this revised edition describes the statistical aspects of both the design and analysis of trials, with particular emphasis on the more recent methods of analysis.

About 8000 clinical trials are undertaken annually in all areas of medicine, from the treatment of acne to the prevention of cancer. Correct interpretation of the data from such trials depends largely on adequate design and on performing the appropriate statistical analyses. This book provides a useful guide to medical statisticians and others faced with the often difficult problems of designing and analysing clinical trials.

Contents:

• An Introduction to Clinical Trials
• Treatment Allocation, the Size of Trials and Reporting Results
• Monitoring Trial Progress: Outcome Measures, Compliance, Dropouts and Interim Analyses
• Basic Analyses of Clinical Trials, the Generalised Linear Model and the Economic Evaluation of Trials
• Simple Approaches to the Analysis of Longitudinal Data from Clinical Trials
• Multivariate Normal Regression Models for Longitudinal Data from Clinical Trials
• Models for Non-Normal Longitudinal Data from Clinical Trials
• Survival Analysis
• Bayesian Methods Longitudinal Data
• Meta-Analysis

"... given a keen amateur interest and an ability to skip the occasional rather daunting-looking equation this book is surprisingly accessible ... There's an introductory chapter containing an excellent historical overview."

“In providing a concise description of the statistical aspects of the design and analysis of clinical trials, free of any major typographical errors, the authors have succeeded. Those concerned with the correct design and analysis of clinical trials, but wishing to avoid either the advanced theoretical aspects or too much focus on application of methodologies, will find this book to be very accessible with relatively up-to-date references.”