Data Monitoring Committees in Clinical Trials (eBook)

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)