Defined broadly, a biomarker is a physiological variable that can be measured objectively and reliably1 and connotes some biological characteristic about the patient in whom it is measured. As such, biomarkers either can be used as a surrogate for a hard end point, correlating with an important clinical outcome of interest, or can be used to provide prognostic information—predictive of future events and, at their best, a tool to influence treatment strategies. In this commentary, we argue that this latter use is the most appropriate application for biomarkers.
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