Lexology February 21, 2024
Last week, the U.S. Food and Drug Administration (FDA) published a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring Committees in Clinical Trials.” In the Federal Register notice announcing the draft guidance, FDA explained that there has been “an increase in the use of DMCs in many disease areas not involving serious morbidity or mortality.” Among other things, FDA noted that DMCs can provide specialized expertise to evaluate safety data for trials in rare diseases, in vulnerable populations, and for oncology drugs with highly specific targets and potentially serious risks.
In the new draft guidance, the agency provides recommendations on when a DMC is advisable and DMC best practices. Notably,...
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