This Article Full Text (PDF) All Versions of this Article: 0962280207081863v1 0962280207081863v2 17/5/477    most recent References Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in Web of Science Similar articles in PubMed Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by Green, E. Articles by Sargent, D. J Search for Related Content PubMed PubMed Citation Articles by Green, E. Articles by Sargent, D. J Social Bookmarking                         What's this?

Surrogate endpoint validation: statistical elegance versus clinical relevance

Division of Biostatistics, Mayo Clinic, Rochester, MN, USA,

G. Yothers

NSABP Statistical Center, Pittsburgh, PA, USA

Daniel J Sargent

Division of Biostatistics, Mayo Clinic, Rochester, MN, USA, sargent.daniel{at}mayo.edu

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.

This version was published on October 1, 2008

Statistical Methods in Medical Research, Vol. 17, No. 5, 477-486 (2008)
DOI: 10.1177/0962280207081863


CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				P. Piedbois and J. Miller Croswell Surrogate endpoints for overall survival in advanced colorectal cancer: a clinician's perspective Statistical Methods in Medical Research, October 1, 2008; 17(5): 519 - 527. [Abstract] [PDF]