Surrogate Endpoint (Response) Biomarker: A response biomarker that is an 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 truly measure a clinical benefit. Rather is expected to predict that clinical benefit based on scientific evidence.
BEST (Biomarkers, EndpointS, and other Tools) Resource. FDA-NIH Biomarker Working Group. Last Updated: November 29, 2021. https://www.ncbi.nlm.nih.gov/books/NBK326791/pdf/Bookshelf_NBK326791.pdf
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