title: Interpreting the clinical utility of a pharmacogenomic marker based on observational association studies.
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.
authors.affiliation: School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, SA, Australia.
authors.forename: M J
authors.initials: MJ
authors.lastname: Sorich
authors.affiliation: Murdoch Childrens Research Institute, Melbourne, VIC, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Coory
mesh_terms: D015415:Biomarkers; D064420:Drug-Related Side Effects and Adverse Reactions / Q000235:genetics*; D019317:Evidence-Based Medicine; D006801:Humans; D064887:Observational Studies as Topic; D010597:Pharmacogenetics; D011237:Predictive Value of Tests; D011379:Prognosis; D012107:Research Design
chemical_list: D015415:Biomarkers