Use of Progression-Free Survival as a Surrogate Marker in Oncology Trials: Some Regulatory Issues

Stat Methods Med Res. 2008 Oct;17(5):515-8. doi: 10.1177/0962280207081862. Epub 2008 Feb 19.

Abstract

There has been interest in using progression-free survival as a surrogate endpoint for overall survival in oncology clinical trials. In order to objectively define this endpoint, clear understanding of what progression means, how it is measured and what its implications are need to be discussed. This article discusses some regulatory aspects of using progression-free survival as an endpoint.

MeSH terms

  • Biomarkers*
  • Clinical Trials as Topic / legislation & jurisprudence*
  • Disease Progression*
  • Government Regulation*
  • Humans
  • Medical Oncology
  • Neoplasms / drug therapy
  • Survival Analysis*
  • United States

Substances

  • Biomarkers