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Statistical Methods in Medical Research
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0962280207081862v1
17/5/515    most recent
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What's this?

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

Aloka Chakravarty

Office of Biostatistics, Center for Drug Evaluation and Research, FDA, MD, USA, aloka.chakravarty{at}fda.hhs.gov

Rajeshwari Sridhara

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

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.

This version was published on October 1, 2008

Statistical Methods in Medical Research, Vol. 17, No. 5, 515-518 (2008)
DOI: 10.1177/0962280207081862
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This article has been cited by other articles:


Home page
 JNCI J Natl Cancer InstHome page
K. R. Broglio and D. A. Berry
Detecting an Overall Survival Benefit that Is Derived From Progression-Free Survival
J Natl Cancer Inst, November 9, 2009; (2009) djp369v1.
[Abstract] [Full Text] [PDF]


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