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Translating biomarkers to clinical practice

Molecular Psychiatry volume 16, pages 1076–1087 (2011)Cite this article

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Abstract

Biomarkers are the measurable characteristics of an individual that may represent risk factors for a disease or outcome, or that may be indicators of disease progression or of treatment-associated changes. In general, the process by which biomarkers, once identified, might be translated into clinical practice has received scant attention in recent psychiatric literature. A body of work in diagnostic development suggests a framework for evaluating and validating novel biomarkers, but this work may be unfamiliar to clinical and translational researchers in psychiatry. Therefore, this review focuses on the steps that might follow the identification of putative biomarkers. It first addresses standard approaches to characterizing biomarker performance, followed by demonstrations of how a putative biomarker might be shown to have clinical relevance. Finally, it addresses ways in which a biomarker-based test might be validated for clinical application in terms of efficacy and cost-effectiveness.

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Acknowledgements

I thank Shaun Purcell, PhD, and Pamela Sklar, MD, PhD, for helpful discussion. This work was supported by R01 MH086026 and by the Stanley Center for Psychiatric Research.

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  1. Department of Psychiatry, Laboratory of Psychiatric Pharmacogenomics, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA

    R H Perlis

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Correspondence to R H Perlis.

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Competing interests

Dr Perlis has received consulting fees and royalties from Concordant Rater Systems and consulting fees from Proteus Biomedical, RIDVentures and Genomind.

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Perlis, R. Translating biomarkers to clinical practice. Mol Psychiatry 16, 1076–1087 (2011). https://doi.org/10.1038/mp.2011.63

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