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Challenges and Opportunities for Biomarker Validation

Hey SP, D'Andrea E, Jung EH, Tessema FA, Luo J, Gyawali B, Kesselheim AS - Journal of Law, Medicine & Ethics

  • Commentary & Opinion
| Fall 2019
  • Regulation and Clinical Evidence

Summary:

Rigorous biomarker validation is critical to clinical practice and drug development. The authors argue that relying on unvalidated biomarkers can harm patients and propose a framework for improving the validation process.

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