Data Monitoring Committees in Clinical Trials

Beschreibung

There has been substantial growth in the use of data monitoringcommittees in recent years, by both government agencies and thepharmaceutical industry. This growth has been brought about byincreasing recognition of the value of such committees insafeguarding trial participants as well as protecting trialintegrity and the validity of conclusions. This very timely bookdescribes the operation of data monitoring committees, and providesan authoritative guide to their establishment, purpose andresponsibilities. * Provides a practical overview of data monitoring in clinicaltrials. * Describes the purpose, responsibilities and operation of datamonitoring committees. * Provides directly applicable advice for those managing andconducting clinical trials, and those serving on data monitoringcommittees. * Gives insight into clinical data monitoring to those sitting onregulatory and ethical committees. * Discusses issues pertinent to those working in clinical trials inboth the US and Europe. The practical guidance provided by this book will be of use toprofessionals working in and/or managing clinical trials, inacademic, government and industry settings, particularly medicalstatisticians, clinicians, trial co-ordinators, and those workingin regulatory affairs and bioethics.

Autor*in

Susan Ellenberg

Themen in »Data Monitoring Committees in Clinical Trials«

Biostatistics Biostatistik Medical Science Medical Sciences Special Topics Medizin Medizinische Statistik Spezialthemen Medizin Statistics Statistik

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"...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)
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