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Biomarkers as Surrogate Endpoints: Ongoing Opportunities for Validation.

Audrey D Zhang1, Joseph S Ross1

  • 1Audrey D. Zhang, A.B., is affiliated with New York University School of Medicine, New York, NY and Center for Outcomes Research and Evaluation, Yale-New Haven Hospital), all New Haven, Connecticut. Joseph S. Ross, M.D., M.H.S., is affiliated with Section of General Internal Medicine, and the National Clinician Scholars Program, Department of Internal Medicine, Yale School of Medicine; Department of Health Policy and Management, Yale School of Public Health; Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, all New Haven, Connecticut.

The Journal of Law, Medicine & Ethics : a Journal of the American Society of Law, Medicine & Ethics
|September 28, 2019
PubMed
Summary

Biomarker surrogate endpoints help estimate clinical trial benefits but face reliability questions. Ongoing validation efforts are crucial, especially as regulatory bodies increasingly support their use.

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