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

Office of Biostatistics, Center for Drug Evaluation and Research, FDA, MD, USA

^* To whom correspondence should be addressed.

	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.

First published on February 19, 2008, doi:10.1177/0962280207081862

Statistical Methods in Medical Research 2008;17:515.

A more recent version of this article appeared on October 1, 2008


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