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

journal contribution
posted on 2023-06-08, 12:03 authored by E Walker, M C Hankins, S M White
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.

History

Publication status

  • Published

Journal

Anaesthesia

ISSN

0003-2409

Publisher

Wiley

Issue

9

Volume

64

Page range

984-989

Department affiliated with

  • Primary Care and Public Health Publications

Full text available

  • No

Peer reviewed?

  • Yes

Legacy Posted Date

2012-07-13

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    University of Sussex (Publications)

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