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Surrogate endpoint validation: statistical elegance versus clinical relevance

¹ Division of Biostatistics, Mayo Clinic, Rochester, MN, USA
² NSABP Statistical Center, Pittsburgh, PA, USA
³ Division of Biostatistics, MayoClinic, Rochester, MN, USA

^* To whom correspondence should be addressed.

	Abstract

A variety of approaches have been proposed to provide formal and informal validation of proposed surrogate markers. To achieve true clinical impact, the validation must convince both the statistical and clinical communities. In this paper, we argue that the best approach is not a single method but a multi-faceted exploration, using multiple approaches, including those that directly appeal to clinicians but with less statistical foundation and those arising from statistical considerations but more difficult to interpret clinically. We illustrate our approach using data from clinical trials in both early and advanced colorectal cancer.

First published on February 19, 2008, doi:10.1177/0962280207081863

Statistical Methods in Medical Research 2008;17:477.

A more recent version of this article appeared on October 1, 2008
This version was published on February 25, 2008


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