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When do I Need a DMC?

October 11, 2021

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When do I Need a DMC?

To better understand when you may need a data monitoring committee (DMC), it’s helpful to know a DMC’s role in research.

When would you have a DMC?

For some trials—particularly blinded and placebo-controlled trials—the sponsor likely doesn’t know if the drug works as predicted until the trial’s end. The only group that will look at masked or unblinded study data is a DMC.

A DMC will keep an eye on the trial while it’s going on. They can detect if a drug isn’t working and can notify the sponsor if the trial needs to stop early or be adjusted.

Why are DMCs needed?

Independent DMC review and oversight is essential for mitigating risks to study participants and ensuring certain types of trials have adequate data safety monitoring plans. There are two guidelines requiring sponsors to have adequate data safety monitoring plans in their clinical protocols:

  1. US Food and Drug Administration (FDA) guidance
  2. Good clinical practice (GCP) E6 R2

US FDA and European Union (EU) European Medicines Agency (EMA) indicate an independent DMC is an effective and appropriate way to provide an adequate safety monitoring plan for clinical trials where:

If any of these attributes apply to your study, establishing an independent DMC or DSMB should be considered. Your institutional review board (IRB), ethics committee (EC), or regulators may require it as well.

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