Routine pharmacogenetic testing in clinical practice: dream or reality?
Pharmacogenetics (PGx) has become progressively popular in recent years, thanks to growing anticipation among scientists, healthcare providers and the general public for the incorporation of genetic tests into the diagnostic arsenal at the physician's disposal. Indeed, much research has been dedicated to elucidation of genetic determinants underlying interindividual variability in pharmacokinetic parameters, as well as drug safety and efficacy. However, few PGx applications have thus far been realized in healthcare management. This review uses examples from PGx research of psychiatric drugs to illustrate why the current published findings are inadequate and insufficient for utilization as routine clinical predictors of treatment safety, efficacy or dosing. I therefore suggest the necessary steps to demonstrate the validity, utility and cost-effectiveness of PGx. These recommendations include a whole range of aspects, starting from standardization of criteria and assessment of the technical quality of genotyping assays, up to design of prospective PGx studies, providing the basis for reimbursement programs to be recognized in routine clinical practice.
Grossman
Iris
I
GlaxoSmithKline, Pharmacogenetics, Research and Development, 5 Moore Drive, Research Triangle Park, Durham, NC 27709, USA. iris.x.grossman@gsk.com
D002986:Clinical Trials as Topic / Q000379:methods* / Q000639:trends; D003955:Diagnostic Tests, Routine / Q000592:standards / Q000639:trends; D006801:Humans; D010597:Pharmacogenetics / Q000379:methods* / Q000639:trends*; D011619:Psychotropic Drugs / Q000009:adverse effects / Q000627:therapeutic use; D015203:Reproducibility of Results; D012107:Research Design; D012449:Safety; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use
D011619:Psychotropic Drugs; D017367:Selective Serotonin Reuptake Inhibitors