title: The effect of the European Clinical Trials Directive on published drug research in anaesthesia.
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.
authors.affiliation: Brighton Anaesthesia Research Forum, Royal Sussex County Hospital, Brighton, East Sussex, UK.
authors.forename: E
authors.initials: E
authors.lastname: Walker
authors.forename: M C
authors.initials: MC
authors.lastname: Hankins
authors.forename: S M
authors.initials: SM
authors.lastname: White
mesh_terms: D000776:Anesthesiology / Q000706:statistics & numerical data / Q000639:trends*; D015706:Bibliometrics; D035843:Biomedical Research / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data / Q000639:trends; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data / Q000639:trends*; D017327:Clinical Trials, Phase IV as Topic / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data / Q000639:trends; D055808:Drug Discovery / Q000331:legislation & jurisprudence; D015507:Drugs, Investigational; D005060:Europe; D005062:European Union; D006801:Humans; D007880:Legislation, Drug; D010506:Periodicals as Topic / Q000706:statistics & numerical data; D011643:Publishing / Q000706:statistics & numerical data / Q000639:trends*
chemical_list: D015507:Drugs, Investigational