我国儿童药物临床试验机构认定基本情况分析  

Analysis of General Information on Pediatric Drug Clinical Trial Institution Identified in China

作　　者：张华吉[1] 李秀记[2] 孙承媛[3] 黄宏星[1] 

机构地区：[1]国家食品药品监督管理总局信息中心,北京100053 [2]中国食品药品检定研究院,北京100050 [3]军事医学科学院卫生勤务与医学情报研究所,北京100039

出　　处：《儿科药学杂志》2014年第10期34-38,共5页Journal of Pediatric Pharmacy

摘　　要：目的:研究我国现有儿童药物临床试验机构及专业的情况,为实施儿童药物临床试验提供信息支持。方法:对国家食品药品监督管理总局网站2005-2013年发布的药物临床试验机构认定公告数据进行整理分析。结果:截至2013年底,全国共有49家药物临床试验机构的134个专业科室可开展儿童药物临床试验,包括10家儿童专科医院的76个专业科室和39家综合医院的58个专业科室。这些机构分布在全国21个省份,其中以东部地区居多,尤其是北京、上海、浙江等;省会城市的儿童药物临床试验机构远多于非省会城市,占全部儿童药物临床试验机构的89.80%;小儿呼吸、中医儿科、小儿肾病、小儿血液、小儿消化等专业获得认定的专业科室较多。结论:我国现有儿童药物临床试验机构不多,呈现地区、专业分布不均衡性,东部地区临床试验机构远多于中西部地区。小儿呼吸、中医儿科、小儿肾病、小儿血液、小儿消化等专业临床试验机构多于其他专业。政府应加强政策引导,鼓励医疗机构及专业科室参与认定;加强医疗资源匮乏地区的投入,减少地区间儿童药物临床试验资源的差距;做到统筹兼顾,平衡医疗资源。Objective： To study the situation of the pediatric drug clinical trial institutions and professional departments in China, provide the information to support the impplementation of pediatric drug clinical trial. Methods： We analysis the data collecting from the drug clinical trial institution database from 2005 to 2013 in the China Food and Drug Administration website. Results： By the end of2013, a total of 134 professional departments in 49 hospitals were identified as pediatric drug clinical trial institutions, including 76 professional departments in 10 children＇ s hospitals and 58 professional departments in 39 general hospitals. These institutions are distributed in 21 provinces, especially Beijing, Shanghai, Zhejiang provinces were in the forefront. The number of pediatric drug clinical trial institutions in capital cities which account for 89.80% of the total was much higher than that of non provincial capital cities. The number of professional departments in the forefront included pediatric respiratory, TCM pediatrics, pediatric kidney disease, pediatric hematology, and pediatric digestive. Conclusion： The number of existing pediatric drug clinical trial institutions is not much, which shows imbalance on region and profession. And the number of pediatric drug clinical trail institutions in the eastern region is far higher than that in the other regions ; For the number of profession, pediatric respiratory, TCM pediatrics, pediatric kidney disease, pediatric hematology, and pediatric digestive were higher than that of the other professional departments. Therefore, the related government department should encourage the medical institutions to participate in the pediatric drug clinical trial institutions, so as to increase the number of the pediatric drug clinical trial institutions and some medical professional departments, and balance the medical resource.

关 键 词：儿童 药物临床试验机构 地域分布 专业分布 

分 类 号：R969.3[医药卫生—药理学]