Use of progression-free survival as a surrogate marker in oncology trials: some regulatory issues.
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.
Chakravarty
Aloka
A
Office of Biostatistics, Center for Drug Evaluation and Research, FDA, MD, USA. aloka.chakravarty@fda.hhs.gov
Sridhara
Rajeshwari
R
D015415:Biomarkers; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D018450:Disease Progression; D033161:Government Regulation; D006801:Humans; D008495:Medical Oncology; D009369:Neoplasms / Q000188:drug therapy; D016019:Survival Analysis; D014481:United States
D015415:Biomarkers