title: The unintended consequences of clinical trials regulations.
abstract: Alex McMahon and colleagues critique the International Conference on Harmonisation (ICH) guidance on good clinical practice (GCP), arguing that it is having a disastrous effect on noncommerical randomized clinical trials in Europe.
authors.affiliation: Dental School, Faculty of Medicine, University of Glasgow, Glasgow, Scotland. a.mcmahon@dental.gla.ac.uk
authors.forename: Alex D
authors.initials: AD
authors.lastname: McMahon
authors.forename: David I
authors.initials: DI
authors.lastname: Conway
authors.forename: Tom M
authors.initials: TM
authors.lastname: Macdonald
authors.forename: Gordon T
authors.initials: GT
authors.lastname: McInnes
mesh_terms: D002986:Clinical Trials as Topic / Q000191:economics / Q000331:legislation & jurisprudence* / Q000592:standards; D003226:Congresses as Topic; D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000191:economics / Q000331:legislation & jurisprudence; D005060:Europe; D019317:Evidence-Based Medicine / Q000191:economics / Q000331:legislation & jurisprudence* / Q000592:standards; D033161:Government Regulation; D006801:Humans; D017410:Practice Guidelines as Topic / Q000592:standards*