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

The effect of the European Clinical Trials Directive on published drug research in anaesthesia
The effect of the European Clinical Trials Directive on published drug research in anaesthesia
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
0003-2409
Walker, E
741d4d8f-01b4-4bdf-8fa1-057cdf9c97f1
Hankins, M.C.
ce4b7d68-3320-4af4-9dd7-3537a4b07219
White, S.M.
f958acb9-acfc-426d-9a18-8d8eef6865a4
Walker, E
741d4d8f-01b4-4bdf-8fa1-057cdf9c97f1
Hankins, M.C.
ce4b7d68-3320-4af4-9dd7-3537a4b07219
White, S.M.
f958acb9-acfc-426d-9a18-8d8eef6865a4

Walker, E, Hankins, M.C. and White, S.M. (2009) The effect of the European Clinical Trials Directive on published drug research in anaesthesia. Anaesthesia, 64 (9). (doi:10.1111/j.1365-2044.2009.06011.x). (PMID:19686484)

Record type: Article

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

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Published date: September 2009

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Local EPrints ID: 187315
URI: http://eprints.soton.ac.uk/id/eprint/187315
ISSN: 0003-2409
PURE UUID: c864e394-b8ac-4145-b7a2-c9d1b501d776

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Date deposited: 17 May 2011 11:48
Last modified: 02 Dec 2019 21:16

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