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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/408

Title: Statistical challenges in the evaluation of surrogate endpoints in randomized trials
Authors: Molenberghs, Geert
Buyse, Marc E.
Geys, Helena
Renard, Didier
Burzykowski, Tomasz
Alonso Abad, Ariel
Keywords: Clinical trials
Clustered data
Surrogate Markers
Issue Date: 2002
Citation: Controlled Clinical Trials, 23(6), PII S0197-2456(02)00236-2. p. 607-625
Abstract: The validation of surrogate endpoints has been studied by Prentice, who presented a definition as well as a set of criteria that are equivalent if the surrogate and true endpoints are binary. Freedman et al. supplemented these criteria with the so-called proportion explained. Buyse and Molenberghs proposed to replace the proportion explained by two quantities: (1) the relative effect, linking the effect of treatment on both endpoints, and (2) the adjusted association, an individual-level measure of agreement between both endpoints. In a multiunit setting, these quantities can be generalized to a trial-level measure of surrogacy and an individual-level measure of surrogacy. In this paper, we argue that such a multiunit approach should be adopted because it overcomes difficulties that necessarily surround validation efforts based on a single trial. These difficulties are highlighted.
URI: http://hdl.handle.net/1942/408
Link to publication: https://www.academia.edu/8393370/Statistical_challenges_in_the_evaluation_of_surrogate_endpoints_in_randomized_trials
DOI: 10.1016/S0197-2456(02)00236-2
ISI #: 000179835100001
ISSN: 0197-2456
Category: A1
Type: Journal Contribution
Validation: ecoom, 2004
Appears in Collections: Research publications

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