" /> Surrogate Endpoint - CISMeF





Preferred Label : Surrogate Endpoint;

NCIt definition : A biomarker that is intended to substitute for a clinical endpoint. A surrogate endpoint is expected to predict clinical benefit (or harm or lack of benefit or harm) based on epidemiologic, therapeutic, pathophysiologic, or other scientific evidence. The term surrogate endpoint applies primarily to endpoints in therapeutic intervention trials; however, it may sometimes apply in natural history or epidemiologic studies. The use of biomarkers as surrogate endpoints in a clinical trial requires the specification of the clinical endpoints that are being substituted, class of therapeutic intervention being applied, and characteristics of population and disease state in which the substitution is being made.;

Alternative definition : CDISC: An endpoint that is 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. (NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource); CDISC-GLOSS: An endpoint that is 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. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource]. See also endpoint.;

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08/05/2025


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