What is an Endpoint Adjudication Committee (EAC)?
An Endpoint Adjudication Committee (EAC), also known as a Clinical Endpoint Committee (CEC), is an independent group of experts that reviews clinical trial data in order to give expert opinions about clinical safety or efficacy events of interest.
Why use Endpoint Adjudication?
Through the clinical, expert review of principal investigator reporting, the EAC process helps to lower the risk of variation in important clinical trial outcome events for submission to regulatory agencies.
The independent adjudication process is especially helpful for enhancing safety and efficacy in the following situations:
- Studies with complex and/or subjective endpoints;
- Studies which cannot be blinded;
- Studies with high enrollment or long duration;
- Studies with global or cultural differences across sites;
- When the endpoint of interest differs from the therapeutic specialty of the investigator.
There is a growing trend across a wide variety of therapeutic areas and medical device studies to adjudicate important endpoints, outcome events, and even inclusion/exclusion criteria that determines whether patients are eligible for a study.