A type of endpoint used in clinical trials as a substitute for a direct measure of how a patient feels, functions, or survives. A surrogate endpoint does not measure the clinical benefit of primary interest in and of itself but rather is expected to predict that clinical benefit or harm based on epidemiologic, therapeutic, pathophysiologic, or other scientific evidence. From a U.S. regulatory standpoint, surrogate endpoints and potential surrogate endpoints can be characterized by the level of clinical validation: (a) validated surrogate endpoints; (b) reasonably likely surrogate endpoints; and (c) candidate surrogate endpoints. (Source: BEST (Biomarkers, Endpoints and Other Tools) Resource)

Scroll to Top