基于潜在狄利克雷分布模型的我国临床试验管理研究热点及其演化分析

目的 分析国内临床试验管理研究领域的研究主题和热点主题的演化过程,揭示其研究现状。方法 本文采用潜在狄利克雷分布模型(Latent Dirichlet Allocation,LDA)对本领域的研究文献进行主题分析,根据主题生命周期坐标图识别热点主题,基于不同发展阶段热点主题所属文献的关键词分析主题内容的演化脉络。结果 国内临床试验管理领域的主要研究主题有13个。按研究内容可分为两类:临床试验的质量管理类和临床试验受试者权益保护类; 按主题的发展类型可分为:5个具有进一步发展潜力的潜在主题、4个具有分化趋势的衰退主题和4个热点主题。热点研究主题的演化脉络既有自身特点,也呈现出一些共性特征。结论 近年来,我国临床试验管理的研究快速发展。热点主题中,临床试验机构管理研究的落脚点从宏观向微观转变、信息管理系统的设计从独立系统转向多系统的融合开发、受试者的权益保护研究的侧重点在发生变化、受试者依从性研究从关注生理向关注心理转变。

Research hotspots and evolution of clinical trial management based on Latent Dirichlet Allocation,China

Objective To analyze the evolution process of research topics and hot topics in the field of clinical trial management research in China, so as to reveal its research status. Methods The Latent Dirichlet Allocation model(LDA)was used to analyze the topic of the research literature in this field. Hot topics were identified according to the coordinate diagram of the topic life cycle, and the evolution of the topic content was analyzed based on the keywords of the literatures of hot topics in different development stages. Results There were 13 main research topics in clinical trial management in China. According to the research content, they could be divided into two categories: quality management of clinical trials, protection of the rights and interests of clinical trial subjects. According to the development type of the theme, they could be divided into five potential themes with further development potential, four declining themes with differentiation tendency and four hot topics. The evolution of hot topics not only had its own characteristics, but also presented some common characteristics. Conclusion In recent years, the study of clinical trial management has developed rapidly in China. In the context of hot topics, the foothold of clinical trial institution management research has changed from macro to micro, the design of information management system has changed from independent system to multi-system integrated development, the focus of research on the protection of subjects’ rights and interests has changed, and the research on subjects’ compliance has changed from focusing on physiology to focusing on psychology.