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The term “biomarker” refers to a characteristic that can be measured objectively, accurately, and reproducibly as an indicator of normal biological processes, pathogenic processes, or pharmacologic response to a therapeutic intervention (Califf 2018; Strimbu and Tavel 2010). Biomarkers should be separated from clinical outcome assessment (COA), which encompasses direct measures of how a patient feels, functions, or survives (Califf 2018). This distinction is important, because therapeutics must meet regulatory standards that rely on COAs for measuring the outcomes. Biomarkers, on the other hand, can serve various purposes, such as predicting a COA on the basis of a measurement. To be used in a clinical setting, biomarkers must undergo rigorous scrutiny and be validated for yielding reliable and reproducible results across multiple populations. Subtypes of biomarkers have been defined according to their applications and classified as diagnostic biomarkers, monitoring biomarkers, pharmacodynamic or response biomarkers, predictive biomarkers, prognostic biomarkers, and safety biomarkers (Califf 2018; see also Table 4.1). Importantly, a biomarker may fall into one or more biomarker subtypes.