Hotspots and Frontiers of Real-world Clinical Research in China in Recent Ten Years
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摘要:
目的:通过对近10年中国发表的真实世界临床研究相关文献进行分析,试图展现这一时期国内真实世界临床研究的基本情况、热点和前沿趋势。方法:计算机检索国家知识基础设施数据库(CNKI)、中文科技期刊数据库(CCD)、中国学术期刊数据库(CSPD)、SinoMed、Web of science及Pubmed等数据库有关国内学者发表的关于真实世界临床研究的文章,时间从2011年9月至2021年9月,运用文献计量工具CiteSpace进行数据挖掘,在中华中医药学会、世界中医药学会联合会、国家药品监督管理局以及美国FDA等网站查找近10年发表的有关真实世界的规范性文件。结果:共纳入有效文献1 525篇,文献发表整体呈现增长趋势,研究范围较广,关键词演化分析表明研究热点主要集中于中药注射剂疗效分析和基于医疗大数据的临床用药特征分析等方面,研究设计类型主要是观察性研究。结论:通过梳理国内真实世界临床研究的发展脉络、方法学、政策支持和证据评估方法,有助于研究人员和临床医生更好地了解真实世界临床研究和提高真实世界证据质量,以期为我国开展高质量真实世界临床研究提供借鉴。
Abstract:
This study aims to analyze the papers on real-world clinical research in China from September 2011 to September 2021,which is expected to reveal the status quo,hot spots,and frontier in this field.Methods:The articles on real-world clinical research published by Chinese scholars from September 2011 to September 2021 were retrieved from China National Knowledge Infrastructure(CNKI),China Science Periodical Database(CSPD),Chinese Citation Database(CCD),SinoMed,VIP,CBM,Web of Science(WOS),and Pubmed.CiteSpace was employed for data mining and normative documents on real world released in this period were searched on official websites of China Association of Chinese Medicine,World Federation of Chinese Medicine Societies,National Medical Products Administration,and FDA of the US.Results:A total of 1 525 eligible articles were screened out,and the articles showed an increasing trend with gradually extensive research scope.The key word evolution analysis suggested that the research focuses were the analysis of the efficacy of Chinese medicine injections and big data-based clinical medication rule analysis,with the main research type of observational study.Conclusion:A summary of the trend,methodology,policies,and evidence evaluation methods of real-world clinical research in China can help gain a clear insight into this field and improve the quality of real-world evidence,thereby providing a reference for high-quality real-world research in China.