目的 分析比较国内外临床试验伦理学的研究现状,为临床试验伦理学考量提供相关建议.方法 检索中国国家知识基础设施(CNKI)和Web of Science数据库核心合集中关于医学伦理学在临床试验方向的论文,应用文献计量学软件CiteSpace绘制国内外文献的知识图谱,对医学伦理学在临床试验方向的研究热点、发展趋势进行分析.结果 在知情同意过程、风险最小化、公平选择以及注重弱势群体权益保护等内容上,中国医学伦理学研究的关注要点与国外基本一致,不同之处在于国外研究比较关注伦理教育、研究参与者的生活质量和伦理咨询等方面的内容;国内研究比较关注临床试验质量管理和中医药研究的特殊性,对弱势群体的研究大多集中在儿童方面,对其他弱势群体的研究较少,总体研究数量和研究关注领域的维度与国外呈现较大差距.结论 中国应加强国内医学伦理学的多维度研究,从仅对伦理审查要点和管理学的研究方面逐渐拓展到更加关注解决临床问题和研究参与者特殊性的应用性研究,增加研究数量、扩大研究维度,确保对研究参与者给予充分的保护.
Comparative Study of Clinical Trial Ethics Between China and Foreign Countries Based on CiteSpace
Objective To provide relevant suggestions for ethical considerations in clinical research by searching literature related to ethics in clinical research using the visualization analysis software CiteSpace,and to analyze and compare the current research status of clinical research ethics at home and abroad.Methods The papers on the application of medical ethics in clinical trials from the core collection of CNKI and Web of Science databases were collected and the bibliometric software CiteSpace was used to draw a knowledge map of domestic and foreign literature.The research hotspots and development trends of medical ethics in clinical trials were analyzed.Results In terms of the process of informed consent,risk minimization,fair selection,and protection on the rights and interests of vulnerable groups,the focus of medical ethics research in China were basically consistent with foreign literature.The difference was that foreign research focused more on ethical education,the quality of life of research participants,and ethical counseling.Otherwise,domestic research focused more on the quality management of clinical trials and the specificity of traditional Chinese medicine research,with research on vulnerable groups mostly focused on children.Conclusion Chinese researchers should strengthen multi-dimensional research on medical ethics in China,and gradually expand their view from ethical review points and management research to applied research solved clinical problems and the specificity of research participants,and increasing the number and dimensions of research.
Medical ethicsClinical trialsBibliometric analysisCiteSpace
万方数据
维普
