Fact Sheet

Biomarkers and Surrogate Endpoints

PhRMA May 13, 2016

Biomarkers have many uses in the drug development process, including providing the ability to track the progress of disease. For a serious disease or condition where there is a significant unmet need, like cancer, the FDA may allow for the use of a surrogate endpoint to demonstrate the effect of a medicine. A surrogate endpoint is a marker—such as a biomarker or other measure—that is expected to predict, but is not itself a measure of clinical benefit, and can thus be substituted for a clinical endpoint.