JSM 2004 - Toronto

Abstract #300825

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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 - #300825
Title: Clinical Trials Data-monitoring Committees: The Who, What, When, and Why of Unmasking
Author(s): Anne S. Lindblad*+
Companies: EMMES Corporation
Address: 401 N. Washington St., Rockville, MD, 20850,
Keywords: DMC membership ; unmasking ; interim data ; clinical trial
Abstract:

Data Monitoring Committees (DMCs), composed of independent experts, review accumulating data within randomized controlled trials and provide recommendations to study sponsors (NIH and/or industry) for study continuation without change, modification, or termination. The recommendation is based on a review of the totality of the information collected within the trial as well as information that may be available publicly. Data from within the trial typically reviewed include, data quality and currency, adherence to study design, enrollment, and safety and efficacy outcome measures. DMCs may meet on a calendar basis or on a study-completion-level basis depending on monitoring guidelines adopted at study initiation. DMC meetings may include nonvoting members. The composition of nonvoting members with respect to their relative independence from study funding and study operation and the level of participation of these nonvoting members in DMC data review, both masked and unmasked, is under debate within the clinical trials community.

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Revised March 2004