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.
Melissa A. Robb, Pamela M. McInnes, Robert M. Califf. Biomarkers and Surrogate EndpointsDeveloping Common Terminology and Definitions. JAMA. 2016;315(11):1107–1108. doi:10.1001/jama.2016.2240