title: Designing pharmacogenetic projects in industry: practical design perspectives from the Industry Pharmacogenomics Working Group.
abstract: Pharmacogenetic association studies have the potential to identify variations in DNA sequence which impact drug response. Identifying these DNA variants can help to explain interindividual variability in drug response; this is the first step in personalizing dosing and treatment regimes to a patient's needs. There are many intricacies in the design and analysis of pharmacogenetic association studies, including having adequate power, selecting proper endpoints, detecting and correcting the effects of population stratification, modeling genetic and nongenetic covariates accurately, and validating the results. At this point there are no formal guidelines on the design and analysis of pharmacogenetic studies. The Industry Pharmacogenomics Working Group has initiated discussions regarding potential guidelines for pharmacogenetic study design and analyses (http://i-pwg.org) and the results from these discussions are presented in this paper.
authors.affiliation: BioStat Solutions Inc., Mount Airy, MD 21771, USA. enab@BioStatSolutions.com
authors.forename: C M
authors.initials: CM
authors.lastname: Bromley
authors.forename: S
authors.initials: S
authors.lastname: Close
authors.forename: N
authors.initials: N
authors.lastname: Cohen
authors.forename: R
authors.initials: R
authors.lastname: Favis
authors.forename: B
authors.initials: B
authors.lastname: Fijal
authors.forename: F
authors.initials: F
authors.lastname: Gheyas
authors.forename: W
authors.initials: W
authors.lastname: Liu
authors.forename: C
authors.initials: C
authors.lastname: Lopez-Correa
authors.forename: A
authors.initials: A
authors.lastname: Prokop
authors.forename: J B
authors.initials: JB
authors.lastname: Singer
authors.forename: A
authors.initials: A
authors.lastname: Snapir
authors.forename: A
authors.initials: A
authors.lastname: Tchelet
authors.forename: D
authors.initials: D
authors.lastname: Wang
authors.forename: D
authors.initials: D
authors.lastname: Goldstaub
mesh_terms: D004345:Drug Industry / Q000592:standards / Q000639:trends*; D023381:Endpoint Determination; D006801:Humans; D010597:Pharmacogenetics / Q000379:methods*; D017410:Practice Guidelines as Topic; D011786:Quality Control; D012107:Research Design / Q000592:standards / Q000639:trends*