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 It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials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The new draft guidance is generally reflective of these developments, and we wanted to highlight several of the changes in this blog post. DMC charters have also grown longer and more detailed. The 2006 guidance noted that these would be “rare cases” limited to “specific issues of urgent concern.”
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