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Data Monitoring Committees Can Support Certain Adaptive Design Trials, US FDA Says

 
• By Brenda Sandburg

Draft guidance describes evolution of DMCs and their responsibilities for monitoring trial conduct, internal analyses and external data.

Clinical trial monitoring
FDA issues draft guindance on use of data monitoriing committees in clinical trials • Source: Shutterstock

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notes the significant changes in the structure and practice of clinical trial data monitoring committees in new draft guidance for sponsors.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

  • Using a DMC instead of an independent adaptation body to support adaptive trials might best be reserved for relatively straight forward designs.

  • DMCs...

The draft guidance, “Use of Data Monitoring Committees in Clinical Trials,” revises a guidance issued in 2006. (Also see "Data Monitoring Committees" - Pink Sheet, 29 March, 2006.)...

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