我国妇幼药物临床试验机构的现状研究  

Current status of maternal and pediatric drug clinical trial institutions in China

作　　者：杨楠 刁莎[1,2,3] 何思颐 刘峥 张普雯 曾力楠[1,2,3] 余勤[3,6] 张伶俐 YANG Nan;DIAO Sha;HE Si-yi;LIU Zheng;ZHANG Pu-wen;ZENG Li-nan;YU Qin;ZHANG Ling-li(Department of Pharmacy/Evidence-Based Pharmacy Center/Children's Medicine Key Laboratory of Sichuan Province,West China Second University Hospital,Sichuan University,Chengdu 610041,China;NMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation,Chengdu 610041,China;Key Laboratory of Birth Defects and Related Diseases of Women and Children,Ministry of Education,Chengdu 610041,China;West China School of Pharmacy,Sichuan University,Chengdu 610041,China;West China School of Medicine,Sichuan University,Chengdu 610041,China;National Drug Clinical Trial Institute,West China Second University Hospital,Sichuan University,Chengdu 610041,China;Chinese Evidence-based Medicine Center,West China Hospital,Sichuan University,Chengdu 610041,China)

机构地区：[1]四川大学华西第二医院药学部/循证药学中心/儿童药物四川省重点实验室,成都610041 [2]国家药品监督管理局药物制剂体内外相关性技术研究重点实验室,成都610041 [3]出生缺陷与相关妇儿疾病教育部重点实验室,成都610041 [4]四川大学华西药学院,成都610041 [5]四川大学华西临床医学院,成都610041 [6]四川大学华西第二医院国家药物临床试验机构,成都610041 [7]四川大学华西医院中国循证医学中心,成都610041

出　　处：《中国新药杂志》2024年第22期2364-2369,共6页Chinese Journal of New Drugs

摘　　要：目的:了解我国妇幼药物临床试验机构备案现状与特点,为妇幼新药研发与临床试验发展提出建议。方法:检索药物临床试验机构备案管理信息平台,截至2023年6月30日,纳入可开展妇产科及儿科药物临床试验的机构或单位,描述性分析我国妇幼药物临床试验机构分布特征。结果:全国累计备案药物临床试验机构1357家,其中妇幼药物临床试验机构548家,备案妇产科专业占比34.05%,备案儿科专业占比20.71%。备案制启动以来,妇幼药物临床试验机构数逐年增加,分布趋势向中东部地区集中,以三级、综合医院为主,妇幼医疗机构占比5.67%。结论:应通过向妇幼药物临床试验机构提供政策激励、优化区域间妇幼药物临床试验资源配置等途径促进妇幼药物临床试验的开展,推动妇幼药物研发。Objective:To understand the current situation of the registration of maternal and pediatric drug clinical trial institutions in China.Methods:The Drug Clinical Trial Institution Filing Management System Platform of National Medical Products Administration of China was searched by computer.Institutions that can carry out obstetrics and gynecology or pediatric drug clinical trials(i.e.,“maternal and pediatric drug clinical trial institutions”)were included with information of their regions,registration number,institution name,institution level,and registered specialties.Descriptive analysis was used to summarize characteristics of maternal and pediatric drug clinical trial institutions in China.Results:As of June 30,2023,1357 drug clinical trial institutions had been registered,of which 548 were maternal and pediatric drug clinical trial institutions.Institutions with registered obstetrics and gynecology specialties accounted for 34.05%of the total registrations,while those with pediatric specialties accounted for only 20.71%.The maternal and pediatric drug clinical trial institutions located more in the east and less in the central and western regions,and were mainly tertiary,comprehensive hospitals.Conclusion:There are problems such as uneven regional distribution and insufficient quantity of maternal and pediatric drug clinical trial institutions in China.It is necessary to promote the development of maternal and pediatric drug clinical trials by providing policy incentives to maternal and pediatric drug clinical trial institutions,optimizing the allocation of resources among regions,standardizing supervision and management,etc.,to promote the research and development of maternal and pediatric drugs.

关 键 词：妇幼健康 新药研发 药物临床试验 药物临床试验机构 备案管理 

分 类 号：R969.4[医药卫生—药理学]