The unintended consequences of clinical trials regulations

PLoS Med. 2009 Nov;3(11):e1000131. doi: 10.1371/journal.pmed.1000131. Epub 2009 Nov 17.

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.

MeSH terms

  • Clinical Trials as Topic / economics
  • Clinical Trials as Topic / legislation & jurisprudence*
  • Clinical Trials as Topic / standards
  • Congresses as Topic
  • Drug Approval / economics
  • Drug Approval / legislation & jurisprudence
  • Drug Industry / economics
  • Drug Industry / legislation & jurisprudence
  • Europe
  • Evidence-Based Medicine / economics
  • Evidence-Based Medicine / legislation & jurisprudence*
  • Evidence-Based Medicine / standards
  • Government Regulation*
  • Humans
  • Practice Guidelines as Topic / standards*