Lexology April 1, 2024
The US Food and Drug Administration (FDA) recently issued draft guidance with recommendations to help clinical trial sponsors determine when a data monitoring committee (DMC) would be beneficial for managing clinical trials and what procedures and practices they should consider when using a DMC, significantly revising past guidance from FDA. The comment period for feedback on the draft guidance is open until April 15.
The draft guidance substantially revises FDA’s 2006 guidance on Establishment and Operation of Clinical Trial Data Monitoring Committees and was prompted by changes in how DMCs are used in current clinical trials. Specifically, FDA notes there has been an increase in DMC use, a trend of longer and more detailed DMC charters, an expansion of DMC...
Today's Sponsors
Today's Sponsor