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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/463

Title: Challenges in the methodology for the validation of surrogate endpoints in randomized trials
Authors: Molenberghs, Geert
Buyse, Marc E.
Geys, Helena
Renard, Didier
Burzykowski, Tomasz
Keywords: Clustered data
Clinical trials
Surrogate Markers
Issue Date: 2002
Citation: Stasinopoulos, Mikis & Touloumi, Giota (Ed.) Proceedings of the 17th International Workshop on Statistical Modelling. p. 491-498.
Abstract: The validation of surrogate endpoints has been studied by Prentice (1989). He presented a definition as well as a set of criteria that are equivalent if the surrogate and true endpoints are binary. Freedman (1992) supplemented these criteria with the so-called proportion explained. Buyse and Molenberghs (1998) 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 this paper, we argue that a meta-analytic approach should be adopted because it overcomes difficulties which necessarily surround validation efforts based on a single trial.
URI: http://hdl.handle.net/1942/463
Link to publication: http://www.statmod.org/files/proceedings/iwsm2002_proceedings.pdf
Category: C2
Type: Proceedings Paper
Appears in Collections: Research publications

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