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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/377

Title: Statistical validation of surrogate endpoints: problems and proposals
Authors: Buyse, Marc E.
Molenberghs, Geert
Burzykowski, Tomasz
Renard, Didier
Geys, Helena
Keywords: Clinical trials
Clustered data
Surrogate Markers
Issue Date: 2000
Publisher: DRUG INFORMATION ASSOCIATION
Citation: Drug Information Journal, 34(2). p. 447-454
Abstract: Prentice proposed a definition of surrogate endpoints and operational criteria for their validation. Freedman supplemented these criteria with the proportion explained, which is supposed to represent the proportion of the treatment effect upon the true endpoint which is mediated by the surrogate endpoint. In this paper, we argue that the proportion explained should be replaced by other quantities, such as the relative effect linking the effects of treatment on both endpoints and an individual-level measure of agreement between both endpoints. The latter quantity carries over naturally when data are available on several randomized experiments, 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 definition of surrogacy, and allows one to predict the effect of treatment upon the true endpoint, given its observed effect upon the surrogate endpoint.
URI: http://hdl.handle.net/1942/377
Link to publication: https://www.researchgate.net/profile/Marc_Buyse/publication/241646459_Statistical_Validation_of_Surrogate_Endpoints_Problems_and_Proposals/links/0c96052d22f6dd1de5000000/Statistical-Validation-of-Surrogate-Endpoints-Problems-and-Proposals.pdf
ISI #: 000087220200013
ISSN: 0092-8615
Category: A1
Type: Journal Contribution
Validation: ecoom, 2001
Appears in Collections: Research publications

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