Almost 18 years after its last formal recommendations on the topic, the US Food and Drug Administration notes the significant changes in the structure and practice of clinical trial data monitoring committees in new draft guidance for sponsors.
Key Guidance Recommendations
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Using a DMC instead of an independent adaptation body to support adaptive trials might best be reserved for relatively straight forward designs.
The draft guidance, “Use of Data Monitoring Committees in Clinical Trials,” revises a guidance issued in 2006. (Also see...
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