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Data Monitoring Committees in Clinical Trials: A Practical Perspective by Ell…

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Book Title
Data Monitoring Committees in Clinical Trials: A Practical Persp
Narrative Type
Engineering
Genre
N/A
Intended Audience
N/A
Subject
Engineering
ISBN
9780471489863
Publication Name
Data Monitoring Committees in Clinical Trials : a Practical Perspective
Item Length
9.3in
Publisher
Wiley & Sons, Incorporated, John
Series
Statistics in Practice Ser.
Publication Year
2002
Type
Textbook
Format
Hardcover
Language
English
Item Height
0.7in
Author
Susan Smith Ellenberg, David L. Demets, Thomas R. Fleming, Susan S. Ellenberg
Item Width
6.5in
Item Weight
16.2 Oz
Number of Pages
208 Pages

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Product Information

There has been substantial growth in the use of data monitoring committees in recent years, 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.

Product Identifiers

Publisher
Wiley & Sons, Incorporated, John
ISBN-10
0471489867
ISBN-13
9780471489863
eBay Product ID (ePID)
1611743

Product Key Features

Author
Susan Smith Ellenberg, David L. Demets, Thomas R. Fleming, Susan S. Ellenberg
Publication Name
Data Monitoring Committees in Clinical Trials : a Practical Perspective
Format
Hardcover
Language
English
Series
Statistics in Practice Ser.
Publication Year
2002
Type
Textbook
Number of Pages
208 Pages

Dimensions

Item Length
9.3in
Item Height
0.7in
Item Width
6.5in
Item Weight
16.2 Oz

Additional Product Features

Series Volume Number
6
Lc Classification Number
R853.C55e455 2002
Reviews
"...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), "...essential reading for anyone establishing, joining or interacting with data monitoring committees..." ( Journal of Clinical Research Practices , September 2007) "...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)
Table of Content
Introduction 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 Index
Copyright Date
2002
Topic
Clinical Medicine, Probability & Statistics / General
Lccn
2002-069017
Dewey Decimal
615.50724
Intended Audience
Scholarly & Professional
Dewey Edition
21
Illustrated
Yes
Genre
Mathematics, Medical

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