Ethical Challenges in Biomarker-Driven Drug Development

Clin Pharmacol Ther. 2018 Jan;103(1):23-25. doi: 10.1002/cpt.862. Epub 2017 Sep 25.


The increasing importance of biomarkers-as drivers of research and drug development activity, surrogate outcomes in clinical trials, and the centerpiece of precision medicine-raises many new ethical challenges. In what follows, I briefly review some of the major ethical challenges and debates already identified in the literature, and then describe a new ethical challenge that arises from the abstract nature of biomarker hypotheses.

MeSH terms

  • Bioethical Issues
  • Biomarkers*
  • Drug Discovery* / ethics
  • Drug Discovery* / methods
  • Endpoint Determination / ethics
  • Endpoint Determination / methods
  • Humans
  • Precision Medicine
  • Technology, Pharmaceutical / ethics
  • Technology, Pharmaceutical / methods


  • Biomarkers