Fundamentals of Clinical Trials - Softcover

Friedman, Lawrence M.; Furberg, Curt D.; DeMets, David L.

Softcover

ISBN 10: 0815133561 ISBN 13: 9780815133568

Publisher: Mosby, 1996

Synopsis

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.

About this title

From the Back Cover:

This is the fourth edition of a very successful textbook on clinical trials methodology, written by three recognized experts who have long and extensive experience in all areas of clinical trials. Most chapters have been revised considerably from the third edition. A chapter on ethics has been added and topics such as noninferiority and adaptive designs now receive considerable discussion. There is much new material on adverse events, adherence, data monitoring, and issues in analysis. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials from a variety of medical disciplines to illustrate the fundamentals. The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan, and reporting the trial results according to the pre-specified objectives. Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful. This book has been successfully used for teaching courses in clinical trial methodology.

About the Author:

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

About this edition

• Publisher: Mosby
• Publication date: 1996
• ISBN 10: 0815133561
• ISBN 13: 9780815133568
• Binding: Paperback
• Edition number: 3
• Number of pages: 352