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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/673

Title: A perspective on surrogate endpoints in controlled clinical trials
Authors: Molenberghs, Geert
Burzykowski, Tomasz
Alonso Abad, Ariel
Buyse, Marc E.
Keywords: Surrogate Markers
Clinical trials
Issue Date: 2004
Publisher: ARNOLD
Citation: Statistical Methods in Medical Research, 13(3). p. 177-206
Abstract: The last couple of decades have seen a large amount of activity in the area of surrogate marker and surrogate endpoint validation, both from a clinical and a statistical perspective. Prentice1 made a pivotal contribution in the context of a single trial. Subsequently, the framework he proposed has been discussed, criticized, and extended. An important class of extensions considers several rather than a single trial. Recently, a lot of work has been done in this so-called hierarchical or meta-analytic framework. In this paper, we review both the single trial and the hierarchical framework. A number of applications, scattered throughout the literature, are brought together. We outline the statistical issues involved in trying to validate surrogate endpoints. Clearly statistical evidence should only be seen as a component in a decision making process that also involves a number of clinical and biological considerations.
URI: http://hdl.handle.net/1942/673
DOI: 10.1191/0962280204sm362ra
ISI #: 000221873600001
ISSN: 0962-2802
Category: A1
Type: Journal Contribution
Validation: ecoom, 2005
Appears in Collections: Research publications

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