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Interpreting the clinical utility of a pharmacogenomic marker based on observational association studies

The Pharmacogenomics Journal volume 14, pages 1–5 (2014)Cite this article

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Abstract

It is increasingly recognized that the clinical utility of a pharmacogenomic marker is a fundamental characteristic influencing the likelihood of successful clinical translation. Although appropriately designed and executed randomized controlled trials generally provide the most valid evidence for the clinical utility of a pharmacogenomic marker, such evidence may not always be available. Observational pharmacogenomic association studies are a common form of evidence available, but the assessment of clinical utility based on such evidence is often not straightforward. This paper aims to provide insight into this issue using a range of illustrative examples.

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Acknowledgements

We thank Brita Pekarsky for her contributions to discussions of the concepts that have been summarized in this manuscript. Financial support for this study was provided by a grant from the National Heart Foundation of Australia (grant number G11A5902) and the National Health and Medical Research Council of Australia (grant number 1028492).

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Authors and Affiliations

  1. School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, SA, Australia

    M J Sorich

  2. Murdoch Childrens Research Institute, Melbourne, VIC, Australia

    M Coory

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  1. M J Sorich
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Correspondence to M J Sorich.

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The authors declare no conflict of interest.

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Sorich, M., Coory, M. Interpreting the clinical utility of a pharmacogenomic marker based on observational association studies. Pharmacogenomics J 14, 1–5 (2014). https://doi.org/10.1038/tpj.2013.35

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