Data Monitoring Committees in Clinical Trials by Susan S Ellenberg

Data Monitoring Committees in Clinical Trials by Susan S Ellenberg

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Summary

There has been substantial growth in the use of data monitoring committees, particularly within the pharmaceutical industry. This growth has brought with it increasing uncertainty regarding regulatory compliance, and the statistician or clinical trials co-ordinator often has to struggle with conflicting information.

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Data Monitoring Committees in Clinical Trials by Susan S Ellenberg

There has been substantial growth in the use of data monitoring committees, particularly within the pharmaceutical industry. This growth has brought with it increasing uncertainty regarding regulatory compliance, and the statistician or clinical trials co-ordinator often has to struggle with conflicting information.
"..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)

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.

SKU Unavailable
ISBN 13 9780471489863
ISBN 10 0471489867
Title Data Monitoring Committees in Clinical Trials
Author Susan S Ellenberg
Series Statistics In Practice
Condition Unavailable
Binding Type Hardback
Publisher John Wiley and Sons Ltd
Year published 2002-07-16
Number of pages 208
Cover note Book picture is for illustrative purposes only, actual binding, cover or edition may vary.