WHITE PAPER
Best Practices with CEVA
Establishing an endpoint adjudication committee and key endpoint management strategy
Feb 02, 2023

Whether focused on efficacy to gauge event rates in treatment group(s) compared to the standard or aiming to collect evidence of safety concerns and unacceptable risk, clinical endpoints are critical statistical measure points to help demonstrate drug safety and efficacy in clinical development and post-market settings.

However, there is considerable variability in current practices by investigators and study teams to classify clinical endpoints. As a result, some regulatory agencies are requiring or may soon require that both formally-designated clinical endpoints and other events of special interest (i.e., outcomes used in safety risk assessments) undergo centralized adjudication by an Endpoint Adjudication Committee, a panel of unbiased, independent experts responsible for reviewing and classifying potential efficacy and/or safety endpoints. In complying with regulations, trial sponsors may need expert guidance on best practices for developing an EAC and overall strategy and oversight of key endpoint objectives and processes, including endpoint data capture, endpoint management and centralized adjudication integration within overall study design and execution.

Contact Us