Fundamentals of Clinical Trials - Softcover

This text provides complete information on all aspects of the development, management and analysis of clinical research to assist clinical researchers and investigators across all disciplines of medicine to critically appraise reports of clinical trials. Consisting of 19 chapters, the first section covers design and development phases of a trial. The second section reviews recruitment techniques, methods for collecting high quality data as well as some common problems in data collection, assessment of adverse effects and quality of life, measures to enhance and monitor participant compliance, techniques of survival analysis, and data monitoring. Other issues covered are: reasons for not withdrawing participants from analysis, subgroup analysis and meta-analysis, phasing out clinical trials, reporting and interpretation of results, and the complexity of undertaking multi-centre studies.

Lawrence M. Friedman, M.D., is Director, Division of Epidemiology and Clinical Applications, National Heart, Lung, and Blood Institute, National Institutes of Health.