Clinical Endpoint
A direct measure of how a patient feels, functions, or survives — such as survival, heart attack, or ability to walk a certain distance. Clinical endpoints provide more definitive evidence than surrogate endpoints but may require larger, longer, and more expensive trials to assess.
Technical Context
Clinical endpoints directly measure outcomes that matter to patients: survival (overall survival — the gold standard), disease events (heart attack, stroke, fracture), functional measures (6-minute walk distance, exercise capacity), and symptom resolution (pain scores, urinary frequency). Clinical endpoints are preferred over surrogate endpoints for regulatory decision-making but may require very large trials (thousands of patients) followed for years to accrue sufficient events. The cardiovascular outcomes trials for GLP-1 RAs used clinical endpoints (MACE events) but required 3,000-17,000 patients followed for 2-5 years to demonstrate statistically significant differences in cardiovascular event rates.