title: Designing pharmacogenomic studies to be fit for purpose.
abstract: The 2010 US FDA-Drug Industry Association (DIA) Pharmacogenomics Workshop, the fifth in a series of meetings that begun in 2002, brought together multidisciplinary experts from regulatory authorities, medical research, healthcare and drug development. This article summarizes the 'Designing Pharmacogenomic Studies to be Fit for Purpose' track in which considerations regarding the use of retrospective and prospective studies were examined in relation to their ability to influence treatment decisions and labeling for drugs. The aim of the session, using real-world examples (KRAS/panitumumab and HLA-B*5701/abacavir), was to identify good scientific principles that would guide the design of studies to identify subgroups of responders during development programs (including marketed drugs), which could subsequently be used to guide treatment decisions.
authors.affiliation: Deane Drug Discovery Institute, Duke University, Durham, NC 27708, USA.
authors.forename: Daniel K
authors.initials: DK
authors.lastname: Burns
authors.forename: Arlene R
authors.initials: AR
authors.lastname: Hughes
authors.forename: Aidan
authors.initials: A
authors.lastname: Power
authors.forename: Sue-Jane
authors.initials: SJ
authors.lastname: Wang
authors.forename: Scott D
authors.initials: SD
authors.lastname: Patterson
mesh_terms: D054316:Biomarkers, Pharmacological / Q000032:analysis; D015195:Drug Design; D004345:Drug Industry / Q000592:standards; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D010597:Pharmacogenetics / Q000592:standards; D012107:Research Design; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D054316:Biomarkers, Pharmacological