Definition

An independent group of experts that monitors patient safety and treatment efficacy data during a clinical trial and can recommend trial modifications or termination.

Example

The DMC reviews unblinded interim analysis showing excess cardiac events in the treatment arm. They recommend stopping enrollment pending further analysis.

Regulatory source

ICH E6, ICH E9

Common mistakes

DMC members having conflicts of interest, or the sponsor not acting promptly on DMC recommendations.

Inspector question

Describe DMC involvement in your clinical trials. How do you ensure their independence and act on recommendations?

Related terms