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

Ellenberg, Susan S.; Fleming, Thomas R.; DeMets, David L.

 
9780471489863: Data Monitoring Committees in Clinical Trials: A Practical Perspective (Statistics in Practice)
Hardcover
ISBN 10: 0471489867 ISBN 13: 9780471489863
Publisher: Wiley–Blackwell, 2002

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.

"synopsis" may belong to another edition of this title.

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.

From the Back Cover

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 this title" may belong to another edition of this title.

Publisher
Wiley–Blackwell
Publication date
2002
Language
English
ISBN 10 
0471489867
ISBN 13 
9780471489863
Binding
Hardcover
Edition number
1
Number of pages
208

Other Popular Editions of the Same Title

9780470854167: Data Monitoring Committees in Clinical Trials: A Practical Perspective

Featured Edition

ISBN 10:  0470854162 ISBN 13:  9780470854167
Publisher: John Wiley & Sons, 2003
Softcover