Surrogate endpoints in randomized cardiovascular clinical trials

Domanski, M; Pocock, S; Bernaud, C; Borer, J; Geller, N; Revkin, J; Zannad, F; (2011) Surrogate endpoints in randomized cardiovascular clinical trials. Fundamental & clinical pharmacology, 25 (4). pp. 411-413. ISSN 0767-3981 DOI:

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Surrogate endpoints predict the occurrence and timing of a clinical endpoint of interest (CEI). Substitution of a surrogate endpoint for a CEI can dramatically reduce the time and cost necessary to complete a Phase III clinical trial. However, assurance that use of a surrogate endpoint will result in a correct conclusion regarding treatment effect on a CEI requires prior rigorous validation of the surrogate. Surrogate endpoints can also be of substantial use in Phase I and II studies to assess whether the intended therapeutic pathway is operative, thus providing assurance regarding the reasonableness of proceeding to a Phase III trial. This paper discusses the uses and validation of surrogate endpoints.

Item Type: Article
Keywords: randomized clinical trials, surrogate endpoints, entice rl, 1989, v8, p431
Faculty and Department: Faculty of Epidemiology and Population Health > Dept of Medical Statistics
Research Centre: Centre for Statistical Methodology
PubMed ID: 20698890
Web of Science ID: 292451700001


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