Ethical Challenges in Biomarker-Driven Drug Development.

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Abstract

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.