title: Drug development: assessment of pharmacogenetic studies by Spanish research ethics committees.
abstract: The decision taken by research ethics committees (RECs) while assessing pharmacogenetic (PGx) substudies as part of international clinical trials is almost unknown. A total of 255 applications of 36 PGx substudies embedded in clinical trials (12 phase 2, 24 phase 3) were submitted to 72 RECs in 2006-2007 by GlaxoSmithKline in Spain. These were trials of 17 different compounds, aimed to be conducted in the five continents. Of the 255 applications, 226 (89%) were directly approved by RECs without raising any queries to the sponsor; 1% (3/255) were plainly rejected by two RECs. The rest (10%) were followed by 64 queries asked by 16 RECs on 25 PGx substudies. Following responses from the sponsor, all but two applications were approved. Thus, the RECs involved finally approved 98% (250/255) of the submitted applications. The requirements specifically raised by two RECs (PGx samples to be transferred to a public biobank or alternatively destroyed immediately, or storage permitted only 5 years after the trial is concluded) could not be met by the sponsor. It can be inferred from the results obtained that ethical and scientific standards implemented by the sponsor in the design, conduct and sample management of PGx substudies satisfied the vast majority (70/72; 97%) of RECs involved in this study.
authors.affiliation: Medical Department, GlaxoSmithKline SA, Tres Cantos, Madrid, Spain. rafael.dal-re@gsk.com
authors.forename: R
authors.initials: R
authors.lastname: Dal-Ré
authors.forename: I
authors.initials: I
authors.lastname: Luque
authors.forename: R
authors.initials: R
authors.lastname: Torres
authors.forename: J
authors.initials: J
authors.lastname: Lahuerta
mesh_terms: D000818:Animals; D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence; D003657:Decision Making; D055808:Drug Discovery / Q000941:ethics* / Q000331:legislation & jurisprudence; D028744:Ethics Committees, Research / Q000331:legislation & jurisprudence; D033161:Government Regulation; D017408:Guidelines as Topic; D006801:Humans; D015337:Multicenter Studies as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence; D017712:Peer Review, Research; D010597:Pharmacogenetics / Q000941:ethics* / Q000331:legislation & jurisprudence; D013030:Spain