云南省部分医院药物临床试验机构备案情况调查与思考  

Thoughts on the Institutions of Drug Clinical Trials in Certain Prefectural and Municipal Hospitals in Yunnan Province

作　　者：自雪梅 尹健彬 杨美芬 赵正科 陈沫 Zi Xuemei;Yin Jianbin;Yang Meifen;Zhao Zhengke;Chen Mo(Office of the State Drug Clinical Trial Agency,People’s Hospital of Chuxiong Yi Autonomous Prefecture,Chuxiong,Yunnan,675000,China)

机构地区：[1]楚雄彝族自治州人民医院国家药物临床试验机构办公室,云南楚雄675000

出　　处：《中国初级卫生保健》2024年第7期20-22,26,共4页Chinese Primary Health Care

摘　　要：目的:了解云南省部分医院药物临床试验机构备案情况及开展药物临床试验的现状,供首次备案药物临床试验机构参考与借鉴。方法:通过药物临床试验机构备案管理信息平台对云南省部分医院药物临床试验机构数量、备案专业等情况进行统计,查询医院官网统计《药物临床试验质量管理规范》(Good Clinical Practice,GCP)工作板块运行情况。结果:截至2023年9月,共调查了13家临床试验机构在备案平台完成备案的医院;13家医院中有10家医院在官网上设立了GCP工作相关的板块,有2家医院未设立独立的GCP工作板块,仅以公告或信息公开的方式宣传GCP工作;肿瘤为备案机构最多的专业。结论:药物临床试验机构首次备案时,可对目前已备案的机构进行充分了解与学习,结合定向培训,综合把控好影响申办者选择药物临床试验机构的因素,更好地完成备案工作。OBJECTIVE To understand the status quo of drug clinical trial institutions in prefectural and municipal hospitals in Yunnan Province,for reference and reference by first-time drug clinical trial institutions.METHODS Through the platform of management information of drug clinical trial institutions,the number of drug clinical trial institutions and the specialty of drug clinical trial registration in the hospitals of prefectural and municipal levels in Yunnan province were counted,and the operation of Good Clinical Practice(GCP)working plate was checked on the official website of the hospitals.RESULTS As of September 26th of 2023,13 clinical trial had completed their registration on the platform,10 hospitals had set up GCP work related sections on their official websites,and 2 hospitals had not set up independent GCP work sections Cancer was the major with the most records.CONCLUSION At the initial filing of clinical trial institutions,it should have a thorough understanding and learning of the currently registered institutions and to comprehensively control the factors that influence the selection of clinical trial institutions by the applicants,to better complete the filing work.

关 键 词：药物临床试验 药物临床试验质量管理规范 药物临床试验机构 备案 

分 类 号：R197[医药卫生—卫生事业管理]