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Review
. 2010 Nov;5(6):463-6.
doi: 10.1097/COH.0b013e32833ed177.

What are biomarkers?

Kyle Strimbu  1 , Jorge A Tavel
Affiliations
Review

What are biomarkers?

Kyle Strimbu et al. Curr Opin HIV AIDS. 2010 Nov.

Abstract

Purpose of review: This article provides working definitions and a conceptual framework to understand the roles of biomarkers in clinical research.

Recent findings: The definitions of the terms discussed in this article--medical signs, symptoms, biomarkers, surrogate endpoints, clinical endpoints, validation--are still under discussion, as are their relationships to each other, but broad consensus has developed in the past decade and a half about the necessity of distinguishing between, in particular, surrogate and clinical endpoints.

Summary: This article outlines the major definitions of the key terms in this field and considers select cases in which misunderstandings about the terms led to flawed research conclusions.

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References

    1. Biomarkers Definition Working Group Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Therapeutics. 2001;69:89–95. - PubMed

    2. This paper was produced by the Biomarkers Definition Working Group, convened by the National Institutes of Health Director's Initiative on Biomarkers and Surrogate Endpoints. The working group brought together leaders in the field of clinical trials and biostatistics from the U.S. National Institutes of Health, the U.S. Food and Drug Administration, academia, and industry to develop consistent, comprehensive definitions of terms relating to the use of biomarkers as surrogate outcomes, and these definitions are frequently cited as the standard in the literature.

    1. WHO International Programme on Chemical Safety Biomarkers in Risk Assessment: Validity and Validation. 2001. Retrieved from http://www.inchem.org/documents/ehc/ehc/ehc222.htm.
    1. WHO International Programme on Chemical Safety Biomarkers and Risk Assessment: Concepts and Principles. 1993. Retrieved from http://www.inchem.org/documents/ehc/ehc/ehc155.htm.
    1. Fleming TR, DeMets DL. Surrogate end points in clinical trials: Are we being misled? Ann Intern Med. 1996;125:605–613. - PubMed

    2. This widely-cited article looks carefully at the past successes and failures of biomarkers as surrogate outcomes in clinical trials, across a variety of research fields. It also explores in some depth the biological circumstances under which “validated” biomarkers can appear to be part of a well-characterized biological process but in fact, because of oversimplification of the processes involved, still mislead investigators.

    1. D'Agostino RB., Jr Debate: The slippery slope of surrogate outcomes. Curr Control Trials Cardiovasc Med. 2000;1:76–78. - PMC - PubMed