某医院研究者发起的临床研究现状与发展对策分析  

Analysis on the Current Situation and Development Countermeasures of Investigator⁃initiated Trail

作　　者：储召群[1] 张语馨 姜梅玲 王健[1] 谢峻[1] Chu Zhaoqun;Zhang Yuxin;Jiang Meiling;Wang Jian;Xie Jun(Department of Science and Technology,Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School,Nanjing 210008,China)

机构地区：[1]南京大学医学院附属鼓楼医院科技处,南京210008

出　　处：《药物流行病学杂志》2022年第12期850-853,共4页Chinese Journal of Pharmacoepidemiology

基　　金：江苏省医院协会医院管理创新研究项目(编号:JSYGY⁃3⁃2020⁃652);南京大学医院管理研究所课题研究项目(编号:NDYG2020009)。

摘　　要：目的:对某医院研究者发起的临床研究(IIT)的现状进行分析,通过了解发展情况及存在的问题,为提升临床研究质量提出发展对策。方法:采用描述性统计方法对某院IIT项目、类型、成果等情况进行分析研究。结果:该院IIT项目逐年提升(平均增长率为21.48%),但干预性和多中心类临床研究增长缓慢;在美国Clinical Trails网站注册的临床研究,干预性临床研究注册数多于观察性临床研究,单中心临床研究注册数多于多中心临床研究项目;临床研究类论文发表量逐年增加,占全院发表论文比例为5.28%。结论:需进一步转变观念,提高临床研究认识;培养人才,打造高水平研究团队;推进临床研究型病房的建立,做好平台支撑;搭建临床研究信息管理平台,实现高效管理。Objective:To analyze the current situation of investigator⁃initiated trail(IIT),understand the current situation and existing problems of clinical research in our hospital,and then put forward development countermeasures to improve the quality of IIT.Methods:The projects and achievements of IIT were analyzed by descriptive statistical methods.Results:The projects of IIT in our hospital had been increasing year by year(the average growth rate was 21.48%),but the growth of interventional and multi⁃center clinical research had been slow;According to the number of IIT registered on the Clinical Trails website abroad,the number of interventional clinical research was registered more than observational clinical research,and the number of single⁃center clinical research was registered more than that of multi⁃center clinical re⁃search projects.The number of clinical research articles had been increasing year by year,and the proportion of clinical re⁃search was 5.28%.Conclusion:We should change concepts and improve clinical research awareness,cultivate talents and build high⁃level research teams,promote the establishment of clinical research wards and provide platform support,and build a clinical research information management platform to achieve efficient management.

关 键 词：临床研究 现状 发展对策 

分 类 号：R969.4[医药卫生—药理学]