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March 15, 2016

Biomarkers and Surrogate Endpoints: Developing Common Terminology and Definitions

Author Affiliations
  • 1Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
  • 2National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, Maryland
  • 3US Food and Drug Administration, Silver Spring, Maryland
JAMA. 2016;315(11):1107-1108. doi:10.1001/jama.2016.2240

Biomarkers, surrogate endpoints, and clinical outcome assessments provide an essential set of tools needed to translate scientific concepts into diagnostic and therapeutic approaches and technologies. Recently, biomarkers have been promoted as offering significant potential for accelerating basic science, drug discovery, and medical product development, as well as improving clinical care.1 Examples of common biomarkers include breast cancer genes 1 and 2, prostate-specific antigen, and hepatitis C virus ribonucleic acid. Although new analytical approaches and omics-based technologies have yielded a rapidly expanding array of biomarkers, precisely how and when they should be used has not been clearly described.

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