Walker E, Hankins M C, White S M
Brighton Anaesthesia Research Forum, Royal Sussex County Hospital, Brighton, East Sussex, UK.
Anaesthesia. 2009 Sep;64(9):984-9. doi: 10.1111/j.1365-2044.2009.06011.x.
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.
麻醉药物的临床适应症是通过同行评审的临床试验出版物制定的。我们对9种全身麻醉期刊在6年内报道的所有人体研究论文进行了文献计量分析（n = 6489），以确定2004年欧洲临床试验指令对源自欧洲和英国的麻醉药物研究报告的任何影响。我们发现89%的研究涉及患者，11%涉及志愿者。在3234项（50%）药物研究中，96%为IV期（上市后）试验。在全球范围内，欧洲临床试验指令出台后的3年里，研究论文数量下降了3.6%（p < 0.004）（欧洲为5%，英国为18%），药物研究论文数量下降了12%（p < 0.001；欧洲为15%，英国为29%）。因此，临床试验指令的出台恰逢欧洲药物研究的下降，尤其是源自英国的研究。我们建议研究人员可以采取一些应对措施，并提议简化IV期临床试验的申请流程，强调患者风险评估。
