FDA Biomarker Guidelines (BEST)

Biomarkers, EndpointS, and other Tools (BEST)

Effective and objective evaluation of biological processes are essential components of evaluating patients, particularly in the context of drug development. Biomarkers are essential components in this regard.

However, in order to translate the results provided by biomarkers, regulators and clinical trialists alike require unambiguous interpretation and communication.

To address this, the FDA-NIH Joint Leadership Council established a framework and vocabulary for how biomarkers can be interpreted, including their use and their significance: the Biomarkers, EndpointS, and other Tools (BEST) glossary.

BEST is developed to accurately distinguish between different biomarker properties, in the context of biomedical research, clinical practice, drug development and regulatory considerations and use. The most frequently used classes of biomarkers in relation to drug development include diagnostic, prognostic, monitoring, response, and predictive biomarkers.

Figure 1. Diagnostic, prognostic, monitoring, and response biomarkers.

Biomarker classifications

A diagnostic biomarker can accurately separate healthy conditions from those affected by disease.

A prognostic biomarker can identify patients that are at a higher likelihood of experiencing disease progression or adverse outcome.

A monitoring biomarker can be used to track development of disease over time or monitor response to treatment.

A response biomarker can be used to pharmacodynamically study the response to treatment.

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