Surrogate Endpoints and Drug Regulation: What Is Needed to Clarify the Evidence

J Law Med Ethics. 2019 Sep;47(3):381-387. doi: 10.1177/1073110519876167.


The FDA's new table of surrogate endpoints used for drug approvals is an important step forward for overseeing the use of biomarkers in clinical trials. Nevertheless, we present several ways in which the table can be improved.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Biomarkers*
  • Drug Approval / legislation & jurisprudence
  • Drug Approval / organization & administration
  • Guidelines as Topic / standards*
  • Humans
  • United States
  • United States Food and Drug Administration*


  • Biomarkers