摘要
目的了解药物临床试验机构备案制实施后我国精神科专业临床试验机构的现状。方法通过检索药物临床试验机构备案管理信息平台备案的精神科专业备案机构和研究者,以及国家药品监督管理局官网公示的精神科药物临床试验数据,对精神科药物临床试验机构地域分布、主要研究者、临床试验数量和类型等相关情况进行统计分析。结果自备案制实施后,截至2023年3月10日,我国精神科专业备案机构共有104家,分布于全国26个省级行政区,备案研究者总数为927人次;除了1家精神专科医院为二级医院外,其余均为三级医院;共有91家机构承接了122项临床试验,承接项目数量排前十的机构中9家为精神专科医院。结论我国精神科专业临床试验机构以三级综合医院精神科为主力,但在临床试验承接方面,精神专科医院占据主要优势,且存在备案机构区域、备案研究者及承担临床试验数量分布不均衡的问题。
AIM To know the current status of clinical trial institutions on psychiatric specialty in China since the drug clinical trial institution registration came into force.METHODS By searching for the psychiatric professional institutions and investigators registrated in the drug clinical trial institution filing management information platform and clinical trial data of psychiatric drugs published on the official website of the National Medical Products Administration,the regional distribution of psychiatric drug clinical trial institutions,principal investigators,and the number and types of clinical trials were statistically analyzed.RESULTS After the implementation of the filing system,as of March 10,2023,there were a total of 104 psychiatric professional filing institutions in China,distributed in 26 provincial-level administrative regions across the country,with a total of 927 registered researchers.Except for one psychiatric hospital,which was a second level hospital,all other hospitals were third level hospitals.A total of 91 institutions had undertaken 122 clinical trials,and among the top ten institutions in terms of project quantity,there were 9 psychiatric hospitals.CONCLUSION The psychiatric departments of the tertiary comprehensive hospitals are the main force for clinical trial institutions registration,but in terms of undertaking clinical trials,specialized psychiatric hospitals have the main advantage,and there are problems such as uneven distribution of registered institutions regions,registered investigators,and the number of clinical trials undertaken.
作者
魏宇梅
方思乔
黄志伟
郑园园
沈一峰
WEI Yu-mei;FANG Si-qiao;HUANG Zhi-wei;ZHENG Yuan-yuan;SHEN Yi-feng(Shanghai Mental Health Center,Shanghai Jiao Tong University School of Medicine,SHANGHAI 200032,China;Medical Science Center,Beijing B&R Pharma Co.,Ltd.,BEIJING 10001l,China;Jilin Neuropsychiatric Hospital,Siping JILIN 136000,China)
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2024年第3期188-191,共4页
Chinese Journal of New Drugs and Clinical Remedies
基金
上海申康医院发展中心医企融合创新支撑技能培训专项(SHDC2022CRS032)
上海转化医学协同创新中心课题(TM202116PT)
上海市精神心理疾病临床医学研究中心课题(19MC1911100)。
关键词
精神病科
医院
临床试验
药物临床试验机构
组织和管理
psychiatric department,hospital
clinical trial
drug clinical trial institutions
organization and administration
