• Fundam Clin Pharmacol · Aug 2011

    Review

    Surrogate endpoints in randomized cardiovascular clinical trials.

    • Michael Domanski, Stuart Pocock, Corine Bernaud, Jeffrey Borer, Nancy Geller, James Revkin, and Faiez Zannad.
    • The National Heart, Lung, and Blood Institute, Bethesda, MD 20892, USA.
    • Fundam Clin Pharmacol. 2011 Aug 1;25(4):411-3.

    AbstractSurrogate 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.© 2010 The Authors Fundamental and Clinical Pharmacology © 2010 Société Française de Pharmacologie et de Thérapeutique.

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