文章摘要
医疗机构内研究者发起临床研究的项目管理思考
Project management of clinical research initiated by investigators in medical institutions
投稿时间:2020-02-25  修订日期:2020-05-05
DOI:
中文关键词: 研究者发起的临床研究  研究者  科研管理
英文关键词: Investigator-Initiated Trail  Investigators  Scientific research management
基金项目:
作者单位E-mail
刘真 首都医科大学附属北京妇产医院 药物临床试验机构办公室 1067100019@qq.com 
王春水 首都医科大学附属北京妇产医院 医学伦理办公室  
代荫梅 首都医科大学附属北京妇产医院 药物临床试验机构办公室  
呼君瑜 首都医科大学附属北京妇产医院 药物临床试验机构办公室  
摘要点击次数: 29
中文摘要:
      目的 在目前国家尚未出台相关政策的情况下,探讨医疗机构研究者发起临床研究(IIT)管理存在的问题和解决办法,为促进医疗机构IIT项目管理提供建议。方法 通过文献调查结合工作实践,分析IIT项目管理现状及其原因,提出建议和对策。结果 IIT的项目在归口管理、选题设计及其延续性、研究团队建设、伦理审查和科研管理人才培养等方面存在问题。中心化管理有利于项目的规范化管理、有利于培养研究人才和团队建设;加强伦理委员的审查意识,培养科研管理人才,提高项目管理效率。结论 IIT作为注册类临床试验的重要补充在推动医学科研发展方面起到了重要的作用,各医疗机构应针对本机构IIT项目管理存在的问题,整合资源、提供平台、培养人才,高质量开展IIT项目。
英文摘要:
      Objective This paper aimed to explore the problems and solutions in the management of Investigator-initiated Trail (IIT), and to provide suggestions especially in the absence of relevant policy supporting. Methods By investigating literature and practicing, we analyzed the current situation of IIT’s management and the reasons, put forward suggestions. Results There were some problems in the project of IIT, such as management department, topic selection, protocol design, continuity , research team construction, ethical review and ability of management personnel. The centralized management will help the standardized management of the projects, the training of investigators and team building, the review awareness strengthening of the ethics committee, improvement of management ability. Conclusion IIT plays an important role in promoting the development of medical scientific research. Medical institutions should integrate resources, provide platforms, train investigators in order to carry out IIT with high quality.
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