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When Do I Need an EAC?

May 4, 2022

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When Do I Need an EAC?

To better understand when you may need an endpoint adjudication committee (EAC), it’s helpful to know the EAC’s role in research.

When Would we Have an EAC?

Why are EACs Needed?

Independent EAC review and oversight is essential for mitigating risks to study participants and ensuring appropriate medical judgment is employed in evaluating individual medical events.

There are two guidelines strongly encouraging the use of an independent group of experts to conduct adjudication activities and reduce the perception of bias:

U.S. FDA and EU EMA indicate an independent EAC can provide valuable insights, particularly for clinical trials where:

If any of these attributes apply to your study, consider establishing an independent EAC or CEC. Your institutional review board (IRB), ethics committee (EC), or regulators may require it as well.

Additional reasons an EAC may be part of a study’s design include:

What Does an EAC Review?

The EAC is typically blinded to treatment assignment and masked to the assigned study arm when assessing events, regardless of whether the trial itself is blinded. This helps ensure the endpoints receive unbiased assessment.

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