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Title: | Statistical challenges in the evaluation of surrogate endpoints in randomized trials | Authors: | MOLENBERGHS, Geert BUYSE, Marc GEYS, Helena RENARD, Didier BURZYKOWSKI, Tomasz ALONSO ABAD, Ariel |
Issue Date: | 2002 | Source: | 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. | Keywords: | adjusted association; meta-analysis; proportion explained; random-effects model; relative effect; surrogate endpoint; validation | Document URI: | http://hdl.handle.net/1942/408 | Link to publication/dataset: | https://www.academia.edu/8393370/Statistical_challenges_in_the_evaluation_of_surrogate_endpoints_in_randomized_trials | ISSN: | 0197-2456 | DOI: | 10.1016/S0197-2456(02)00236-2 | ISI #: | 000179835100001 | Rights: | (C) 2002 Elsevier Science Inc. All rights reserved. | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2004 |
Appears in Collections: | Research publications |
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