4.3 Article

Biomarkers as Surrogate Endpoints: Ongoing Opportunities for Validation

Journal

JOURNAL OF LAW MEDICINE & ETHICS
Volume 47, Issue 3, Pages 393-395

Publisher

SAGE PUBLICATIONS INC
DOI: 10.1177/1073110519876170

Keywords

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Funding

  1. Yale University from Johnson and Johnson
  2. Medtronic, Inc.
  3. Food and Drug Administration (FDA) [U01FD004585]
  4. Food and Drug Administration [U01FD005938]
  5. Blue Cross Blue Shield Association
  6. Centers of Medicare and Medicaid Services (CMS) [HHSM-500-2013-13018I]
  7. Agency for Healthcare Research and Quality [R01HS022882]
  8. National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) [R01HS025164]
  9. Laura and John Arnold Foundation
  10. FDA Yale-Mayo Clinic CERSI [U01FD005938]

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Surrogate endpoints are a common application of biomarkers to estimate clinical benefit in clinical trials, despite questions about reliability. This article discusses ongoing opportunities for their validation, in the context of a regulatory environment in which they are increasingly championed.

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