The effect of the European Clinical Trials Directive on published drug research in anaesthesia

Anaesthesia. 2009 Sep;64(9):984-9. doi: 10.1111/j.1365-2044.2009.06011.x.

Abstract

The clinical indications for anaesthetic drugs are developed through peer-reviewed publication of clinical trials. We performed a bibliometric analysis of all human research papers reported in nine general anaesthesia journals over 6 years (n = 6489), to determine any effects of the 2004 European Clinical Trials Directive on reported drug research in anaesthesia originating from Europe and the United Kingdom. We found 89% studies involved patients and 11% volunteers. Of 3234 (50%) drug studies, 96% were phase IV (post-marketing) trials. Worldwide, the number of research papers fell by 3.6% (p < 0.004) in the 3 years following introduction of the European Clinical Trials Directive (5% Europe, 18% United Kingdom), and drug research papers fell by 12% (p < 0.001; 15% Europe, 29% United Kingdom). The introduction of the Clinical Trials Directive has therefore coincided with a decline in European drug research, particularly that originating from the United Kingdom. We suggest a number of measures researchers could take in response, and we propose a simplification of the application process for phase IV clinical trials, emphasising patient risk assessment.

MeSH terms

  • Anesthesiology / statistics & numerical data
  • Anesthesiology / trends*
  • Bibliometrics
  • Biomedical Research / legislation & jurisprudence
  • Biomedical Research / statistics & numerical data
  • Biomedical Research / trends
  • Clinical Trials as Topic / legislation & jurisprudence
  • Clinical Trials as Topic / statistics & numerical data
  • Clinical Trials as Topic / trends*
  • Clinical Trials, Phase IV as Topic / legislation & jurisprudence
  • Clinical Trials, Phase IV as Topic / statistics & numerical data
  • Clinical Trials, Phase IV as Topic / trends
  • Drug Discovery / legislation & jurisprudence
  • Drugs, Investigational
  • Europe
  • European Union
  • Humans
  • Legislation, Drug
  • Periodicals as Topic / statistics & numerical data
  • Publishing / statistics & numerical data
  • Publishing / trends*

Substances

  • Drugs, Investigational