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14 - Monitoring of Clinical Trials:

Interim Monitoring, Data Monitoring Committees, and Group Sequential Methods

from Section 3

Published online by Cambridge University Press:  05 May 2012

By
Rickey E. Carter  and
Robert F. Woolson
Edited by
Bernard Ravina ,
Jeffrey Cummings ,
Michael McDermott  and
R. Michael Poole
Bernard Ravina
Affiliation:
Biogen Idec., Cambridge, MA
Jeffrey Cummings
Affiliation:
Cleveland Clinic, Lou Ruvo Center for Brain Health, Las Vegas
Michael McDermott
Affiliation:
University of Rochester
R. Michael Poole
Affiliation:
AstraZeneca PLC, Waltham, MA, US
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Summary

Accumulating data may be reviewed regularly in all phases of clinical development for decision-making based on safety or clinical benefit. This chapter discusses the process of reviewing accumulating clinical trial data in a formal manner. It provides an overview of the structure and the operations of a data monitoring committee (DMC), and elucidates the statistical issues and challenges of interim monitoring. The chapter describes several commonly used approaches for interim monitoring. Multi-center trials must be coordinated and administered efficiently. A DMC's objectivity is in part due to independence of the members. A formal statistical framework can enhance the objectivity by providing a universal language to communicate the accumulating evidence. Group sequential methods for determining the critical values to be used during interim analyses represent a key advancement in the theory and application of sequential analyses. EAST is highly regarded as an excellent tool for interim monitoring of clinical trials.

Keywords

statistical conceptsmedical interventionneurological clinical trialrandomized clinical trialInstitutional Review BoardsBayesian statisticsbiostatistics
Type
Chapter
Information
Clinical Trials in Neurology
Design, Conduct, Analysis
 , pp. 147 - 159
Publisher: Cambridge University Press
Print publication year: 2012

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