The unintended consequences of clinical trials regulations.
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.
McMahon
Alex D
AD
Dental School, Faculty of Medicine, University of Glasgow, Glasgow, Scotland. a.mcmahon@dental.gla.ac.uk
Conway
David I
DI
Macdonald
Tom M
TM
McInnes
Gordon T
GT
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*