Data Monitoring Committees in Clinical Trials: A Practical Perspective Kindle Edition Pdf Download

Data Monitoring Committees in Clinical Trials: A Practical Perspective (Statistics in Practice) Kindle Edition
Author: Susan S. Ellenberg ID: B000PY456G

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File Size: 2278 KBPrint Length: 208 pagesPublisher: Wiley; 1 edition (December 10, 2007)Publication Date: December 10, 2007 Sold by:  Digital Services, Inc. Language: EnglishID: B000PY456GText-to-Speech: Enabled X-Ray: Not Enabled Word Wise: Not EnabledLending: Not Enabled Enhanced Typesetting: Not Enabled Best Sellers Rank: #1,214,511 Paid in Kindle Store (See Top 100 Paid in Kindle Store) #1153 in Kindle Store > Kindle eBooks > Nonfiction > Science > Mathematics > Applied > Probability & Statistics #8190 in Books > Science & Math > Mathematics > Applied > Probability & Statistics #500720 in Books > Reference
Susan Ellenberg is a Professor of Biostatistics at the University of Pennsylvania. Prior to that she played a prominent role in the development of statistical methods for clinical trials at the US Food and Drug Administration. She made major contributions to the Harmonization Committee’s ICH Guidelines on statistical methods in clinical trials, particularly the Guideline E9.

Tom Fleming and David DeMets are Professor of Biostatistics at University of Washington and Wisconsin University respectively. They are among the world’s leading experts in group sequential methods. Fleming is famous for the O’Brien-Fleming stopping rule that bears his name and DeMets is known for the Lan-DeMets alpha spending function approach to group sequential analysis.

With such experts and excellent writers you get what you should expec t, an authoritative treatment of the practical and technical aspects of the monitoring of data by Data Monitoring Committees (DMCs, previously called Data Safety and Monitoring Boards, DMSBs). These committees look at interim data from a clinical trial to judge whether the trial should be stopped early for safety concerns. In their charter they can set-up their own rule or can debate and make subjective decisions. These authors through their experience present examples and also formal statistical methods that can be used not only to stop for safety concerns but also to stop if safety and efficacy are demonstrated earlier than anticipated in the design. Also if the trial is clearly going to be unsuccessful they can stop for futility as well.

The development of group sequential methods and adaptive designs make a formal analysis for the DMC possible. For a detailed account of group sequential methods see the book by Jennison and Turnbull.
Download Data Monitoring Committees in Clinical Trials: A Practical Perspective Kindle Edition Pdf Download

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