摘要
目的了解我国近20年来临床试验受试者招募研究热点及趋势,为国内药物临床试验机构有效解决受试者招募难题提供科学的解决思路。方法运用文献计量分析法对国内三大数据库2001—2021年相关文献进行研究,分析年度发文量、期刊分布、机构分布、区域分布及高频关键词共现等关键指标。结果通过对筛选的162篇文献进行分析得出,该领域发文量总体呈上升趋势,研究机构呈现多元化特点,主要集中在医疗卫生机构及医药类院校。当前研究热点为受试者保护、伦理审查、法规制定及科学管理等围绕受试者招募提质增效的工作。结论该领域研究取得了长足发展,但整体研究水平仍较落后,应充分发挥国家宏观调控职能,从顶层设计着手,推动受试者招募规范化管理体系建设,不断加大受试者保护力度,提升科学招募效能。同时通过促进优势资源下沉,充分释放基层潜能,发挥体量优势,重视Ⅰ期临床试验始动效能,发挥传统医学强大内生动能,推动我国中医药发展,为我国探索"临床研究型医院"转型发展提供有效支撑,助力我国新药研发高质量发展。
Objective This study is to understand the hot spots and trends in the recruitment of clinical trial subjects in China over the past 20 years,explore the existing problems and countermeasures,and provide scientific ideas for domestic clinical trial institutions to effectively solve the problem of subject recruitment.Methods Bibliometric analysis was used to study the relevant literature from three major domestic databases from 2001 to 2021,analyzing key indicators such as annual publication volume,journal distribution,institutional distribution,regional distribution,and high-frequency keyword co-occurrence.Results A total of 162 articles were selected.The results showed that the overall publication volume in this field showed an upward trend,and the research institutions were diversified,with a concentration of medical and pharmaceutical institutions and universities.The current research hotspots in this field focused on quality and efficiency improvement of subject recruitment,with themes of subject protection,ethical review,regulation development,standardized management,etc.Conclusions The research in this field has made significant progress,but the overall research level is still relatively weak.Therefore,it is suggested that the country should play a role in macro-regulation,on the one hand,starting with top-level design,promoting the construction of a standardized management system for subject recruitment,continuously strengthening subject protection,and enhancing the effectiveness of scientific recruitment.On the other hand,releasing the potential of grassroots institutions and giving full play to the volume advantage by promoting the sinking of advantageous resources.Meanwhile,great importance should be attached to the development of Phase I clinical trials,giving full play to the strong internal energy of traditional medicine and promoting the development of Chinese traditional medicine.These multi-measures should provide a theoretical basis for exploring the transformation of′clinical research hospitals′,and promote the high-quality development of new drug research and development in China.
作者
王炳蔚
马良
韩若岩
郭嘉成
宋鸣
赵颖
崔可可
郑燕
马文杰
刘艳艳
Wang Bingwei;Ma Liang;Han Ruoyan;Guo Jiacheng;Song Ming;Zhao Ying;Cui Keke;Zheng Yan;Ma Wenjie;Liu Yanyan(Affiliated Cancer Hospital of Zhengzhou University/Henan Cancer Hospital,Zhengzhou 450008,China;Henan Integrative Medicine Hospital,Zhengzhou 450004,China)
出处
《中华医学科研管理杂志》
2023年第5期351-355,共5页
Chinese Journal of Medical Science Research Management
基金
河南省医学科技攻关计划项目——联合共建项目(LHGJ20210219)。
关键词
临床试验
受试者招募
文献计量学
研究热点
对策分析
Clinical trial
Subject recruitment
Bibliometrics
HotSpot research
Countermeasure analysis
作者简介
通信作者:刘艳艳,Email:yyliu@zzu.edu.cn,电话:0371-65587610。
