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The unintended consequences of clinical trials regulations McMahon AD; Conway DI; Macdonald TM; McInnes GTPLoS Med 2009[Nov]; 3 (11): e1000131Alex 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.|*Government Regulation[MESH]|Clinical Trials as Topic/economics/*legislation & jurisprudence/standards[MESH]|Congresses as Topic[MESH]|Drug Approval/economics/legislation & jurisprudence[MESH]|Drug Industry/economics/legislation & jurisprudence[MESH]|Europe[MESH]|Evidence-Based Medicine/economics/*legislation & jurisprudence/standards[MESH]|Humans[MESH]|Practice Guidelines as Topic/*standards[MESH] |
