Chakravarty Aloka, Sridhara Rajeshwari
Office of Biostatistics, Center for Drug Evaluation and Research, FDA, MD, USA.
Stat Methods Med Res. 2008 Oct;17(5):515-8. doi: 10.1177/0962280207081862. Epub 2008 Feb 19.
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.
在肿瘤学临床试验中，人们一直对使用无进展生存期作为总生存期的替代终点感兴趣。为了客观地定义这一终点，需要讨论对进展意味着什么、如何测量进展以及其影响有清晰的理解。本文讨论了将无进展生存期用作终点的一些监管方面。
