FDA Draft Guidance Focuses on Trial Use of Data Monitoring Committees; Comments Due April 15

In a new draft guidance, the Food and Drug Administration (FDA) addresses the increased use of data monitoring committees (DMC) by clinical trial sponsors, including academic institutions, to review research data in many disease areas. In the draft, FDA “strongly recommends” a DMC review of the trial if human subjects are at risk of serious morbidity or mortality.  A clinical trial... Read More