How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials
The FDA Law Blog
MARCH 7, 2024
The new draft guidance is generally reflective of these developments, and we wanted to highlight several of the changes in this blog post. In 2006, FDA stated that DMCs were not recommended “for most clinical studies,” particularly those in early product development, short-term studies, or studies addressing less severe outcomes.
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