基于文献分析法的药物临床试验信息化建设

Information construction of drug clinical trials based on literature analysis

目的:梳理药物临床试验信息化建设研究脉络,了解并掌握药物临床试验信息化建设研究热点和发展趋势。方法:本研究采用知识图谱CiteSpaceⅤ软件,在2000年至2020年中国知网数据库391条文献的基础上,从文献数量分析、研究机构分析、作者分析、研究热点主题以及研究趋势分析等角度进行了深入探讨,并绘制知识图谱,梳理药物临床试验信息化建设研究脉络。结果:分析表明近20年来药物临床信息化建设相关研究论文发表数量波动上升,主要研究机构在该领域大都有较强的研究能力,但研究机构间的联系还较为松散,学者间的学术交流还有待加强。在热点研究上的转变体现了该领域更加注重系统化和保护受试者权益。结论:药物临床试验信息化建设研究热点主要集中于临床试验、药物临床试验、质量控制等方面。通过信息化建设进一步提高试验管理效能,保证药物临床试验可靠规范,有效降低药物临床试验风险隐患是未来研究趋势。

AIM:To sort out the research context of information construction of drug clinical trials and understand the hot spots and development trend of informatization construction of drug clinical trials.METHODS:The knowledge map CiteSpaceⅤsoftware was applied to analyze the 391 items of literature collected from China CNKI database during the year of 2000 to 2020.A thorough investigation was conducted from the perspectives of quantitative analysis,research institutes,author,research hot topics and the research trend.A knowledge map was generated to sort out the main ideas of the research of the drug clinical trial information construction.RESULTS:The results showed that in the past 20 years,the number of published papers related to the construction of clinical information of drugs fluctuated,and most of the major research institutions had strong research ability in this field.But the interactions within research institutions remained improved,and the academic exchanges between scholars still needed to be strengthened.The shift in hot-spot research reflected a greater focus on systematizing and protecting subjects'rights.CONCLUSION:The research of information construction of drug clinical trial mainly focuses on clinical trial,drug clinical trial,quality control and other aspects.It is the trend of future research to further improve the efficacy of trial management through information construction,ensure the reliability and standard of drug clinical trials,and effectively reduce the risks and hidden dangers of drug clinical trials.