DescriptionThere 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.
Responsibilities of the Data Monitoring Committee and Motivating Illustrations
Composition of a Data Monitoring Committee
Independence of the Data Monitoring Committee: Avoiding Conflicts of Interest
Confidentiality Issues Relating to the Data Monitoring Committee
Data Monitoring Committee Meetings
Data Monitoring Committee Interactions with Other Trial Components or Related Groups
Statistical, Philosophical and Ethical Issues in Data Monitoring
Determining When a Data Monitoring Committee Is Needed
Regulatory Considerations for the Operation of Data Monitoring Committees
""...meets an important need...of interest to the broad spectrum of individuals ivolved in clinical trials..."" (Controlled Clinical Trials)
""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 for reference…"" (Bulletin of Medical Ethics, February 2003)
""…an excellent starting point …for anyone involved in setting up a data monitoring committee for a clinical trial…"" (Short Book Reviews, April 2003)
""…an extremely useful addition…highly recommended…"" (Statistical Methods in Medical Research, Vol.12, No.2, 2003)
""...highly recommended, perhaps even required, for those on DMC's...a book well written. I recommend it for library purchase."" (The Statistician)
""......clearly required reading for scientists working on clinical trials..."" (Good Clinical Practice Journal, Dec 2003)
""...would recommend it to any statistician in the pharmaceutical industry who has any dealing with DMCs..."" (Pharmaceutical Statistics, Vol 2, 2003)
""There is very little to criticize about this book…[it] is well written, addressing philosophical, statistical and practical issues…"" (Statistics in Medicine, 2004; 23)
“…well organized…invites the reader to go on…” (Statistical Methods in Medical Research, No.13 2004)