SpringerProtocols: Abstract: Biomarkers and Surrogates in Clinical Studies

8. Biomarkers and Surrogates in Clinical Studies

By: Claudio Rigatto¹

, Brendan J. Barrett

Abstract

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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.

Affiliation(s): (1) St. Boniface General Hosptial, 409 Tache Avenue, Winnipeg, MB R2H 2A6, Canada

Book Title: Clinical Epidemiology: Practice and Methods

Series: Methods in Molecular Biology | Volume: 473 | Year: 2009 | Page Range: 1-18 | DOI: 10.1007/978-1-59745-385-1_8

Subject: Molecular Medicine

Key Words: Biomarkers - risk factors - prognosis - diagnosis - intervention studies - surrogate outcomes - validation studies

References

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