The choice of the term "marker" used to indicate a marker of biological drug response (biomarker) or the clinical outcomes (surrogate marker) originates from clinical medicine, where markers are used to indicate absence or presence of a disease (diagnostic purpose) and/or predict the rate and extent of disease progression (prognostic purpose).
As shown in Fig. 2, these markers are strongly tied to our understanding of the pathophysiology of the disease (POD) being treated. The use of markers in clinical medicine for diagnostic or prognostic purposes is justified based on epidemiological and/or interventional clinical studies that assess their ability to predict clinical outcomes.
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