What evidence do we need for biomarker qualification?

Sci Transl Med. 2017 Nov 22;9(417):eaal4599. doi: 10.1126/scitranslmed.aal4599.


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.

Publication types

  • Review

MeSH terms

  • Animals
  • Biomarkers*
  • Humans
  • United States
  • United States Food and Drug Administration


  • Biomarkers