Surrogate endpoints in randomized cardiovascular clinical trials.

Abstract:

: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.

journal_name

Fundam Clin Pharmacol

authors

Domanski M,Pocock S,Bernaud C,Borer J,Geller N,Revkin J,Zannad F

doi

10.1111/j.1472-8206.2010.00865.x

subject

Has Abstract

pub_date

2011-08-01 00:00:00

pages

411-3

issue

4

eissn

0767-3981

issn

1472-8206

pii

FCP865

journal_volume

25

pub_type

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