Best Practices: Establishing An Endpoint Adjudication Committee And Key Endpoint Management Strategy

For many reasons, clinical endpoint classification practices performed by investigators vary. A reliable method to improve consistency for the conclusions drawn from analysis of endpoint outcome data, impacting treatment safety and efficacy, is needed. For many years, the U.S. Food and Drug Administration and other regulatory agencies have suggested that trial sponsors may consider establishing an EAC to determine if endpoints meet protocol-specific criteria. The FDA’s 2006 guidance notes, “Such committees are particularly valuable when endpoints are subjective and/or require the application of complex definition, and when the intervention is not delivered in a blinded fashion.”

Charged with centrally reviewing and classifying suspected efficacy and/or safety endpoints in a blinded and unbiased manner, EACs can determine whether they meet protocol definitions (endpoint criteria) but can also provide endpoint outcomes for critical decision-making in a more standardized method. EACs review overall subject and endpoint-specific data, applying complex medical definitions to provide standardized adjudicated outcomes. It should be noted that with a few exceptions (e.g., single arm trials), EACs are blinded to treatment when performing centralized adjudication, whether or not trial is conducted in a blinded manner, to ensure decisions are made without bias.