Data Monitoring Committees in Clinical Trials (eBook)
208 Seiten
Wiley (Verlag)
978-0-470-85415-0 (ISBN)
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.
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.
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.
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.
Introduction
Responsibilities of the Data Monitoring Committee and MotivatingIllustrations
Composition of a Data Monitoring Committee
Independence of the Data Monitoring Committee: Avoiding Conflictsof Interest
Confidentiality Issues Relating to the Data MonitoringCommittee
Data Monitoring Committee Meetings
Data Monitoring Committee Interactions with Other Trial Componentsor Related Groups
Statistical, Philosophical and Ethical Issues in DataMonitoring
Determining When a Data Monitoring Committee Is Needed
Regulatory Considerations for the Operation of Data MonitoringCommittees
Index
"...essential reading for anyone establishing, joining orinteracting with data monitoring committees..." (Journal ofClinical Research Practices, September 2007)
"...meets an important need...of interest to the broad spectrumof individuals ivolved in clinical trials..." (Controlled ClinicalTrials)
"This wonderful addition to Wiley's 'Statistics in Practice'series is the definitive how-to-do-it manual for running a DMC.."(IRB: Ethics & Human Research , January/February 2003)
"...This is the sort of book that RECs need access to forreference..." (Bulletin of Medical Ethics, February 2003)
"...an excellent starting point ...for anyone involvedin setting up a data monitoring committee for a clinicaltrial..." (Short Book Reviews, April 2003)
"...an extremely useful addition...highlyrecommended..." (Statistical Methods in Medical Research,Vol.12, No.2, 2003)
"...highly recommended, perhaps even required, for those onDMC's...a book well written. I recommend it for library purchase."(The Statistician)
"......clearly required reading for scientists working onclinical trials..." (Good Clinical Practice Journal, Dec 2003)
"...would recommend it to any statistician in the pharmaceuticalindustry who has any dealing with DMCs..." (PharmaceuticalStatistics, Vol 2, 2003)
"There is very little to criticize about this book...[it] iswell written, addressing philosophical, statistical and practicalissues..." (Statistics in Medicine, 2004; 23)
"...well organized...invites the reader to goon..." (Statistical Methods in Medical Research, No.132004)
| Erscheint lt. Verlag | 17.1.2003 |
|---|---|
| Reihe/Serie | Statistics in Practice |
| Sprache | englisch |
| Themenwelt | Mathematik / Informatik ► Informatik ► Datenbanken |
| Mathematik / Informatik ► Mathematik ► Statistik | |
| Mathematik / Informatik ► Mathematik ► Wahrscheinlichkeit / Kombinatorik | |
| Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie | |
| Medizin / Pharmazie ► Pharmazie | |
| Technik | |
| Wirtschaft | |
| Schlagworte | Biostatistics • Biostatistik • Medical Science • Medical Sciences Special Topics • Medizin • Medizinische Statistik • Spezialthemen Medizin • Statistics • Statistik |
| ISBN-10 | 0-470-85415-4 / 0470854154 |
| ISBN-13 | 978-0-470-85415-0 / 9780470854150 |
| Informationen gemäß Produktsicherheitsverordnung (GPSR) | |
| Haben Sie eine Frage zum Produkt? |
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