Use of progression-free survival as a surrogate marker in oncology trials: some regulatory issues

Chakravarty, Aloka; Sridhara, Rajeshwari
October 2008
Statistical Methods in Medical Research;Oct2008, Vol. 17 Issue 5, p515
Academic Journal
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.


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