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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/366

Title: The validation of surrogate endpoints in meta-analyses of randomized experiments
Authors: Buyse, Marc E.
Molenberghs, Geert
Burzykowski, Tomasz
Renard, Didier
Geys, Helena
Keywords: Clinical trials
Clustered data
Surrogate Markers
Issue Date: 2000
Citation: Biostatistics, 1(1). p. 49-67
Abstract: The validation of surrogate endpoints has been studied by Prentice (1989). He presented a definition as well as a set of criteria, which are equivalent only if the surrogate and true endpoints are binary. Freedman et al. (1992) supplemented these criteria with the so-called ‘proportion explained’. Buyse and Molenberghs (1998) proposed replacing the proportion explained by two quantities: (1) the relative effect linking the effect of treatment on both endpoints and (2) an individual-level measure of agreement between both endpoints. The latter quantity carries over when data are available on several randomized trials, while the former can be extended to be a trial-level measure of agreement between the effects of treatment of both endpoints. This approach suggests a new method for the validation of surrogate endpoints, and naturally leads to the prediction of the effect of treatment upon the true endpoint, given its observed effect upon the surrogate endpoint. These ideas are illustrated using data from two sets of multicenter trials: one comparing chemotherapy regimens for patients with advanced ovarian cancer, the other comparing interferon-{alpha} with placebo for patients with age-related macular degeneration.
URI: http://hdl.handle.net/1942/366
Link to publication: http://biostatistics.oxfordjournals.org/cgi/content/abstract/1/1/49
DOI: 10.1093/biostatistics/1.1.49
ISSN: 1465-4644
Category: A1
Type: Journal Contribution
Appears in Collections: Research publications

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