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JNCI Journal of the National Cancer Institute 2004 96(3):173; doi:10.1093/jnci/96.3.173
© 2004 by Oxford University Press
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© 2004 Oxford University Press

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Can Disease-Free Survival Be a Surrogate for Overall Survival for Drug Approvals?

Charles Marwick

The first 10% of the full text of this article appears below.

The gold standard test for clinical benefit of oncology drugs is improvement in overall survival. The U.S. Food and Drug Administration allows drugs to be approved if they improve patient survival or if there is evidence that reliably predicts clinical benefit, such as an established surrogate.

In a recent analysis of the 57 oncology drug applications approved in the last 13 years through the regular approval process (in contrast to the accelerated approval process), two-thirds of them . . . [Full Text of this Article]


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