国内药物临床试验相关伦理审查文献计量学及可视化分析

Bibliometrics and visualization analysis of research papers on Ethical Review of drug clinical trials in China

目的了解国内药物临床试验相关伦理审查研究的发展动态,为今后的研究提供参考依据。方法通过检索中国知网和万方全文数据库,回顾2003—2020年间国内药物临床试验相关伦理审查研究的文献资料,采用文献计量学和可视化方法对文献的发文量、期刊分布、文献作者和关键词等进行统计分析。结果纳入符合标准的文献336篇,文献发文量呈缓慢增长趋势,公开发表在107种期刊上;《中国医学伦理学》杂志载文量最多(53篇);南京中医药大学附属医院参与发文量最多;北京、江苏和上海地区的医疗和科研机构发文排前3位;熊宁宁、刘海涛、陆麒、汪秀琴和吴翠云合作研究强度最大;近年研究热点以受试者保护、跟踪审查、多中心临床试验、孕妇受试者、儿童临床试验、药物临床试验质量管理规范和新型冠状病毒肺炎为主;获得11种省级以上研究基金的资助。结论通过文献计量和可视化的手段,对广大研究者梳理本领域知识结构、进展情况,寻求合作交流,改进不足和论文投稿等均有参考作用。

Objective To better understand the development of domestic drug clinical trial ethical review related research,and provide possible reference for future studies.Methods The data were searched and extracted from the databases such as CNKI,WANFANG.Research Papers on Ethical Review of drug clinical trials in China from 2003 to 2020 were reviewed.Bibliometric and visualization method was used to analyze the number of publications,journal categories,authors,key words,et al.Results 336 papers were selected according to the criteria.The number of published papers was increasing slowly during the years.These papers were published in 107 journals,authors from the Affiliated Hospital of Nanjing University of Chinese Medicine participated in the largest publications.Beijing,Jiangsu and Shanghai ranked among the top three in terms of papers published by medical and scientific research institutions.The largest numbers of such paper were published in Chinese Journal of Medical Ethics(53).The most collaborative authors were Xiong Ningning,Liu Haitao,Lu Qi,Wang Xiuqin,Wu Cuiyun.The research hotspots were human subject protection,post-approval management,multi-center clinical trials,pregnant participant,clinical trials involving children,Good Clinical Practice and COVID-19 in recent years.There were about 11 kinds of research funding from provincial level and higher.Conclusions It is helpful for researchers to understand the knowledge structures,latest progress,seeking for cooperation and communication,improvement and paper submission in their fields of ethical review through bibliometrics and visualization analysis.