JSM 2004 - Toronto

Abstract #300666

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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 - #300666
Title: What is Enough? Preparation of DMC Reports on Interim Data
Author(s): Marian R. Fisher*+
Companies: University of Wisconsin, Madison
Address: 610 Walnut St., Room 215, Madison, WI, 53726,
Keywords: DMC ; interim analysis ; sample report
Abstract:

The DMC's primary responsibility is to ensure, throughout the trial duration, risks to patients are reasonable in relation to anticipated benefit. DMC reports, based on interim accumulating data, need to be thorough, timely, and objective. Study performance is included as well as treatment efficiacy and occurrence of adverse events. Interim data from different sources (e.g., accrual information, SAE reports, CRF data) should be analyzed. The specific structure or content need not be fixed and may change during the trial's course. Many factors (such as stage of the trial, nature of accumulating data, focus of a DMC meeting, and requests by DMC members) will influence report content or how data items are analyzed and presented. The report format should enable large amounts of information to be communicated in a manner that is both maximally informative and easy to review in a short period of time. A sample report produced from the Beta-Blocker Heart Attack Trial is available at www.biostat.wisc.edu/clintrials/sdac/reportprod.html.

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Revised March 2004