Blood pressure as an example of a biomarker that functions as a surrogate
Journal Title: The AAPS Journal - Year 2006, Vol 8, Issue 1
Abstract
There are many important uses of biomarkers in drug development. An area of particular interest is the use of biomarkers as surrogate end points. Only a small minority of biomarkers are established surrogate end points. Blood pressure is an example of a surrogate end point accepted by both clinicians and regulators. It was a plausible surrogate because of the large epidemiologic databases demonstrating a correlation between elevated blood pressures and adverse cardiovascular outcomes. That plausibility has been supported, however, by the numerous placebo-controlled outcome studies evaluating several pharmacologically distinct agents that showed an effect on stroke and coronary heart disease outcomes from lowering blood pressure.
Authors and Affiliations
Mehul Desai, Norman Stockbridge, Robert Temple
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The online version of this article (doi:10.1208/s12248-010-9204-2) contains supplementary material, which is available to authorized users.