Interpreting the clinical utility of a pharmacogenomic marker based on observational association studies
MJ Sorich, M Coory
PHARMACOGENOMICS JOURNAL | NATURE PUBLISHING GROUP | Published : 2014
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.
Awarded by National Heart Foundation of Australia
Awarded by National Health and Medical Research Council of Australia
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).