我国药物临床试验机构的地域及专业分布

Regional and Professional Distribution of Clinical Drug Trial Institutions in China

目的:了解我国药物临床试验机构的地域和专业分布状况,为临床试验的实施提供有益的信息。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的公告数据进行整理、分析。结果:截至2013年底,全国共认定403家临床试验机构的2 982个专业科室。从地域看,列临床试验机构数量前10位的省份中,有8个是东部省份,其中以北京、上海、广东等最多;省会城市的临床试验机构数量远高于非省会城市,占全部临床试验机构的80%。从专业看,列专业科室数量前10位的省份中,有7个是东部省份;西医专业科室数量占全部总认定数量的79.3%,中医专业仅占20.7%;心血管、消化、呼吸、肿瘤等专业分别认定252、227、225、213家,居各认定专业的前列。结论:应鼓励医疗机构参与临床试验机构的认定,增加临床试验机构和某些专业科室的认定数量;加强欠发达地区的医疗资源投入,平衡地区差异;出台有关政策引导一些专业的认定数量,做到统筹兼顾,平衡临床试验机构资源。

OBJECTIVE： To study the regional and professional distribution of clinical drug trial institutions in China, and to provide the information to support the conduction of clinical trial. METHODS： The data from the drug clinical trial institution data- base （2005-2013） issued by CFDA website were summarized and analyzed. RESULTS： By the end of 2013, a total of 2 982 professional departments in 403 hospitals were identified as clinical trial institution. Among top 10 institutions, 8 clinical trail institutions located in the eastern region, especially in Beijing, Shanghai and Guangdong province. 80% clinical trial institutions came from the provincial capital cities, which were far more than those of non-provincial capital cities. Among top 10 professional departments, 7 departments came from the eastern regions; western medicine professional departments accounted for 79.3% of the total, while TCM professional accounts for only 20.7%. The professional department in the forefront included 252 cardiovascular departments, 227 digestive departments, 225 respiratory departments, 213 tumor departments, etc. CONCLUSIONS： The related government department should encourage the medical institutions to participate in the identification of clinical drug trial institution so as to increase the number of clinical trial institution and professional departments; enhance the input of medical resource in undeveloped area and balance regional difference; publish related policies to guide the identification of professional institutions so as to give overall consideration and balance medical resource.