Journal
CONTROLLED CLINICAL TRIALS
Volume 23, Issue 6, Pages 607-625Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/S0197-2456(02)00236-2
Keywords
adjusted association; meta-analysis; proportion explained; random-effects model; relative effect; surrogate endpoint; validation
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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. (C) 2002 Elsevier Science Inc. All rights reserved.
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