What is a Clinical Endpoint Committee (CEC) responsible for?

A Clinical Endpoint Committee (CEC) is primarily responsible for assessing whether specific events of interest have occurred in a clinical trial. This committee plays a crucial role in determining the validity of endpoints that are critical to establishing the efficacy and safety of a treatment being tested. The CEC usually consists of independent experts who review and evaluate clinical outcomes to ensure that the assessment is unbiased and based on predetermined criteria, which enhances the integrity of trial results.

Assessing whether an event of interest—such as a stroke, heart attack, or other prespecified endpoints—has occurred relies on a rigorous examination of evidence and may involve adjudicating cases based on medical records, imaging results, and other relevant documentation. This function is vital for accurately reporting trial outcomes and ensuring that only clinically significant events are considered in the final analysis.

In this context, the other options represent different functions that are not aligned with the primary responsibilities of a CEC. While options related to statistical analyses, determining adverse events, and providing demographic data are important for various aspects of trial management and reporting, they do not encapsulate the specific focus and objective of a Clinical Endpoint Committee.