Term
Hard endpoint
A clinical event, symptom or function outcome, or a regulator-accepted disease-defining measure, as this site's rubric defines it.
On this site, 'hard' means the endpoint measures something that matters clinically in its own right: a clinical event, a symptom or function outcome (clinical remission, endoscopic healing, exacerbations, survival), or an objective physiological measure that regulators accept as an approvable primary endpoint for that disease, such as FEV1 in asthma and COPD, blood pressure in hypertension, HbA1c in type 2 diabetes, or percent weight change in obesity.
The distinction matters for grading: a well-designed trial on a hard primary endpoint can reach the top grade; the same design on an unvalidated marker cannot, because the extra inference from marker to benefit is exactly where drugs fail in later trials.
On this site: The full rubric ↗
Related terms