摘要
目的总结我国医院GCP中心(临床试验研究中心)近20年的研究现状及发展趋势。方法利用中国知网、维普网及万方数据库,检索GCP中心的相关文献,使用NoteExpress处理文献,运用CiteSpace 6.2.R3软件对期刊来源、研究作者及关键词等内容进行可视化分析。结果纳入有效文献4753篇,文章收录最多的杂志为《中国新药杂志》(111篇)。文献作者合作网络分析显示,GCP中心研究领域发文量最多的作者为胡思源(40篇)。排名靠前的关键词显示GCP中心研究主要涉及临床试验(频次603)、临床疗效(频次348)、随机对照试验(频次241)等相关领域。结论近20年来GCP中心开展的药物试验越来越多。建立标准的管理模式,加快GCP中心智慧建设,加强GCP中心质量控制,规范试验人员操作行为,提高科室成员的职业素养,是GCP中心未来的发展趋势,也是保证受试者的安全性和试验过程规范化的重要前提和试验结果科学、真实、可靠的重要保障。
Objective To summarize the research status and development trends of GCP centers(clinical trial research centers)in hospitals in China in the past 20 years.Methods Using CNKI,VIP,and Wanfang databases,relevant literature from GCP centers was searched.NoteExpress was used to process the literature,and CiteSpace 6.2.R3 software was used to visualize and analyze the journal sources,research authors,and keywords.Results Including 4753 valid articles,and the magazine with the most articles included was"Chinese Journal of New Drugs"(111 articles).Analysis of literature author collaboration network showed that Hu Siyuan(40 articles)had the highest number of published articles in the research field of GCP centers.The keywords in the top rankings showed that the GCP centers mainly involves clinical trials(frequency 603),clinical efficacy(frequency 348),randomized controlled trials(frequency 241)and other related fields.Conclusion In the past 20 years,GCP centers have been conducting more and more drug trials.Establishing a standardized management model,accelerating the intelligent construction of GCP centers,strengthening quality control of GCP centers,standardizing the operational behavior of trial personnel,and improving the professional literacy of department members are the future development trend of GCP centers,and are also important prerequisites for ensuring the safety of subjects and standardizing the trial process,as well as important guarantees for scientific,truthful,and reliable trial results.
作者
袁汝奎
王明利
周安琴
陈美娟
YUAN Rukui;WANG Mingli;ZHOU Anqin;CHEN Meijuan(School of Pharmacy,Southwest Medical University,Luzhou 646000,China;Clinical Trial Research Center,The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University,Luzhou 646000,China;Clinical Pharmacy,The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University,Luzhou 646000,China)
出处
《药学研究》
CAS
2024年第3期282-287,共6页
Journal of Pharmaceutical Research
基金
2023年中央财政中医药事业传承与发展补助资金项目(中医药循证能力提升项目)(No.2100601)
2022年泸州市科技计划(重点研发)项目(No.2022-SYF-37)。
