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.
What benefits have clients realized by using ACI’s EAC solutions?
Our EAC solutions have helped clients:
- Achieve consistent, global data collection
- Steer trials in the right direction
- Catch safety issues early on
- Assess risk with event findings
- Bolster regulatory strategy prior to submission
- Submit data and gain expanded labeling
- Provide data and gain additional post-approval labeling
- Receive optimized reimbursement
- Drive increased adoption through publication support
- Gain competitive advantage over other products
Why does the industry trust ACI’s Adjudication Services?
ACI Clinical is the industry leader in EAC management, bringing clients a proprietary, global network of more than 500 vetted medical experts who can serve as committee members or expert advisors. We support our EACs with the largest committee dedicated staff in the industry and a proprietary, end-to-end technology platform that enables efficient, user-friendly adjudication workflow and decision-making.
We partner with clinical trial sponsors, academic experts and regulatory agencies to enhance trial integrity, reduce variation in important clinical trial events and ultimately mitigate risk and enhance patient safety in clinical trials.