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伊朗临床试验注册中心:从构思到世界卫生组织主要登记处的历程和挑战。

Iranian Registry of Clinical Trials: path and challenges from conception to a World Health Organization primary register.

机构信息

Department of Epidemiology, Iran University of Medical Sciences, Tehran, Iran.

出版信息

J Evid Based Med. 2009 Feb;2(1):32-5. doi: 10.1111/j.1756-5391.2009.01002.x.

Abstract

OBJECTIVE

Following the reforms in 1985 in which medical education was integrated into the National Health Service, we have witnessed an increase in teaching, training, and research capacity, improvement in quality of services, and a major boost in medical research in Iran. Following the surge in research activity, the need for public registration of clinical trials was raised within academic circles, particularly after the initiative by the International Committee of Medical Journal Editors in 2004.

METHOD

In line with this global movement, the Iranian Registry of Clinical Trials was developed by a team of Iranian researchers with support from the Ministry of Health and Medical Education.

RESULTS

In our experience, the challenges for developing a national registry for clinical trials are: (i) choosing a committed, versatile leader with the skills and expertise to work and communicate with a variety of stakeholders and other people involved in the process; (ii) securing the necessary resources and political support to minimize resistance and act as a positive force for implementing changes; (iii) developing strong liaison between the information technology team and website administrators to develop a highly functioning website; and (iv) developing the culture of transparency within society in general, and the research community in particular, which goes far beyond setting up a registry.

CONCLUSION

The Iranian Registry of Clinical Trials has made a good start, and should fulfill its mission of providing an accessible source of information for the general public and researchers. This is the goal we have set ourselves.

摘要

目的

1985 年医疗教育纳入国家卫生服务体系进行改革后,我们见证了伊朗教学、培训和研究能力的提高,服务质量的改善,以及医学研究的重大推动。随着研究活动的激增,学术界提出了对临床试验进行公共注册的需求,特别是在 2004 年国际医学期刊编辑委员会倡议之后。

方法

为响应这一全球运动,由伊朗研究人员团队在卫生部和医学教育部的支持下开发了伊朗临床试验注册中心。

结果

根据我们的经验,为临床试验开发国家登记册所面临的挑战是:(i)选择一位有能力、有才华的、有奉献精神的领导者,具备与各种利益相关者和其他参与该过程的人员进行合作和沟通的技能和专业知识;(ii)确保获得必要的资源和政治支持,以最小化阻力,并为实施变革提供积极力量;(iii)在信息技术团队和网站管理员之间建立强大的联系,以开发一个功能强大的网站;以及(iv)在社会中,特别是在研究界中,培养透明度文化,这远远超出了建立登记册的范畴。

结论

伊朗临床试验注册中心已经有了一个良好的开端,应该能够履行其为公众和研究人员提供可访问的信息来源的使命。这是我们设定的目标。

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