What evidence do we need for biomarker qualification?

Predictable steps are needed to determine the evidence required for confident use of a biomarker in drug development. Biomarkers can facilitate all aspects of the drug development process. However, biomarker qualification—the use of a biomarker that is accepted by the U.S. Food and Drug Administration—needs a clear, predictable process. We describe a multistakeholder effort including government, industry, and academia that proposes a framework for defining the amount of evidence needed for biomarker qualification. This framework is intended for broad applications across multiple biomarker categories and uses.

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