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The effect of the European Clinical Trials Directive on published drug research in anaesthesia.
- Source :
- Anaesthesia; Sep2009, Vol. 64 Issue 9, p984-989, 6p, 1 Black and White Photograph, 2 Graphs
- Publication Year :
- 2009
-
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. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 00032409
- Volume :
- 64
- Issue :
- 9
- Database :
- Complementary Index
- Journal :
- Anaesthesia
- Publication Type :
- Academic Journal
- Accession number :
- 43522942
- Full Text :
- https://doi.org/10.1111/j.1365-2044.2009.06011.x