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Biomarkers and Surrogates in Clinical Studies

  • Claudio Rigatto
  • Brendan J. Barrett
Protocol
Part of the Methods in Molecular Biology™ book series (MIMB, volume 473)

Abstract

Biomarkers are defined as anatomic, physiologic, biochemical, molecular, or genetic parameters associated with the presence, absence, or severity of a disease process. As such, biomarkers may be useful as prognostic and diagnostic tests. Establishing the utility of a given biomarker as a prognostic or diagnostic test requires the conduct of carefully designed cohort studies in which the biomarker and the outcome of interest are measured independently. The design and analysis of such studies is discussed.

Surrogate outcomes in clinical trials consist of events or biomarkers intended to reflect important clinical outcomes. Surrogate outcomes may offer advantages in providing statistically robust estimates of treatment effects with smaller sample sizes. However, to be useful, surrogate outcomes have to be validated to ensure that the effect of therapy on them truly reflects the effect of therapy on the important clinical outcomes of interest.

Keywords

Biomarkers risk factors prognosis diagnosis intervention studies surrogate outcomes validation studies 

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Copyright information

© Humana Press, a part of Springer Science+Business Media, LLC 2008

Authors and Affiliations

  1. 1.St. Boniface General HosptialWinnipegCanada

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