TABLE 2-1 Categories of Biomarker Use

Use

Description

Discovery

Identification of biochemical, image, or other biomarkers associated with a disease, condition, or behavior of interest; biomarkers identified may be screened for many potential uses, including as a target for intervention to prevent, treat, or mitigate a disease or condition

Early product development

Biomarkers used for target validation, compound screening, pharmacodynamic assays, safety assessments, and subject selection for clinical trials, and as endpoints in early clinical screening (i.e., phase I and II trials)

Surrogate endpoints for claim and product approvals

Biomarkers used for phase III clinical testing and biomarkers used to substantiate claims for product marketing

Clinical endpoints

Biomarkers used as endpoints for clinical trials that measure how a patient feels, functions, or survives; for example, measures of depression, blindness, and muscle weakness are biomarkers that may be used as clinical endpoints

Clinical practice

Biomarkers used by clinicians for uses such as risk stratification, disease prevention, screening, diagnosis, prognosis, therapeutic monitoring, and posttreatment surveillance

Clinical practice guidelines

Biomarkers used to make generalized recommendations for healthcare practitioners in the areas of risk stratification, disease prevention, treatment, behavior/lifestyle modifications, and more

Comparative efficacy and safety

Biomarkers used in clinical studies looking at the relative efficacy, safety, and cost effectiveness of any or all interventions used for a particular disease or condition, including changes in behavior, nutrition, or lifestyle; these studies are a component of comparative effectiveness research

Public health practice

Biomarkers used to track public health status and make recommendations for prevention, mitigation, and treatment of diseases and conditions at the population level



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