Data Monitoring Committees in Clinical Trials: A Practical Perspective (Statistics in Practice)

DeMets, David L.

ISBN 10: 0471489867 / ISBN 13: 9780471489863

Published by Wiley, 2002

About this Item

The book has been read, but is in excellent condition. Pages are intact and not marred by notes or highlighting. The spine remains undamaged.

Seller Inventory # GOR005805623

Bibliographic Details

• Title: Data Monitoring Committees in Clinical Trials: A Practical Perspective (Statistics in Practice)
• Publisher: Wiley
• Publication Date: 2002
• Language: English
• ISBN 10: 0471489867
• ISBN 13: 9780471489863
• Binding: Hardback
• Condition: Very Good
• Weight: 499 grams

About this title

Synopsis

There has been substantial growth in the use of data monitoring committees in recent years, by both government agencies and the pharmaceutical industry. This growth has been brought about by increasing recognition of the value of such committees in safeguarding trial participants as well as protecting trial integrity and the validity of conclusions. This very timely book describes the operation of data monitoring committees, and provides an authoritative guide to their establishment, purpose and responsibilities.

• Provides a practical overview of data monitoring in clinical trials.
• Describes the purpose, responsibilities and operation of data monitoring committees.
• Provides directly applicable advice for those managing and conducting clinical trials, and those serving on data monitoring committees.
• Gives insight into clinical data monitoring to those sitting on regulatory and ethical committees.
• Discusses issues pertinent to those working in clinical trials in both the US and Europe.

The practical guidance provided by this book will be of use to professionals working in and/or managing clinical trials, in academic, government and industry settings, particularly medical statisticians, clinicians, trial co-ordinators, and those working in regulatory affairs and bioethics.

About the Author

SUSAN S. ELLENBERG, PHD, is Professor of Biostatistics, Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania Perelman School of Medicine, USA.

THOMAS R. FLEMING, PHD, is Professor of Biostatistics and Statistics, Department of Biostatistics, School of Public Health, University of Washington, USA.

DAVID L. DEMETS, PHD, is Professor Emeritus and Founding Chair of the Department of Biostatistics and Medical Informatics, University of Wisconsin–Madison, USA.