Skip to main content

Primary Endpoint

Meaning

The Primary Endpoint is the main result or outcome measure that a clinical trial is specifically designed to evaluate and that will be used to determine if the intervention, such as a new hormonal therapy, is successful. This endpoint must be clearly defined, clinically relevant, and objectively measurable, serving as the definitive basis for regulatory approval and clinical decision-making. All statistical power calculations and the entire trial design are centered around this specific measure of efficacy.