JSM 2004 - Toronto

Abstract #300831

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Activity Number: 402
Type: Topic Contributed
Date/Time: Thursday, August 12, 2004 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #300831
Title: Clinical Trial DMCs: Flexible Approaches for Optimal Monitoring
Author(s): Andreas Sashegyi*+
Companies: Eli Lilly and Company
Address: Lilly Corporate Center, Indianapolis, IN, 46285,
Keywords: data-monitoring committee ; interim analysis ; data analysis group
Abstract:

The regulatory environment of pharmaceutical development is one of ever-increasing focus on patient safety and minimization of sponsor involvement in any aspect of clinical trial conduct that could bias the final results. Consequently, the role of interim analyses of accumulating data in clinical trials and the processes that govern such analyses have recently received a great deal of attention. The FDA draft guidance on DMCs, issued in late 2001, was the first document to formally suggest principles for the establishment and operation of DMCs. In particular, it focuses on registration trials, recommending sponsor-independent DMCs, and also suggesting independent data analysis groups. Using the draft guidance as a starting point, we discuss the various components of the interim analysis/DMC process and their broader application to any trial which might include interim analyses. We suggest appropriate adaptations of the DMC process to a given study, depending on its purpose, phase, and endpoint. Guidelines are presented to aid in deciding on the optimal monitoring strategy.

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