FDA Acceptance of Surrogate End Points for Cancer Drug Approval: 1992-2019

JAMA Intern Med. 2020 Jun 1;180(6):912-914. doi: 10.1001/jamainternmed.2020.1097.


This retrospective review assesses the frequency of surrogate measures used for the first time vs subsequent times in a cancer setting and the surrogate’s strength of correlation with patient-centered outcomes.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antineoplastic Agents / pharmacokinetics*
  • Biomarkers, Tumor / metabolism*
  • Drug Approval / legislation & jurisprudence*
  • Humans
  • Neoplasms / drug therapy*
  • Neoplasms / metabolism
  • Retrospective Studies
  • United States
  • United States Food and Drug Administration*


  • Antineoplastic Agents
  • Biomarkers, Tumor