3. What is a biomarker?

  • The drug developer’s ultimate goal is to show benefit in clinical end-points (i.e., how a patient survives, feels and functions).
  • A biomarker [1] is, contradistinction to a clinical end-point, ‘a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention’.
  • Using this inclusive definition of biomarkers, even very well established measurements, such as blood pressure, or objective tumor response, are properly described as biomarkers, not clinical end-points.
  • Biomarkers can give early readouts, before clinical benefit is evident, and help drug developers identify the best investigational drugs, doses, schedules, combinations, and indications to prioritize. [2]
  • Biomarkers can help predict which patient should receive which drug (stratified medicine or personalized healthcare).

[1] Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Clin Pharm Ther. 2001;69:89-95.

[2] Qualification of imaging biomarkers for oncology drug development. Eur J Cancer 2012;48(4):409-415.


IMI oncology projects