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首都医科大学附属北京儿童医院药物临床试验机构是第一个获批具有儿童药物临床试验资格的机构,同时是目前我国具有儿童药物临床试验资格专业数量最多的机构。截止2015年5月,共承担了110项儿童药物临床试验。在工作中积累了丰富的儿童药物临床试验管理经验,但也存在诸多问题:承接药物临床试验项目数量在各专业分布不均;药物临床试验项目类别分布不均以及不同专业间药物临床试验完成质量差别大。本文从我院药物临床试验现状入手,分析存在的问题及提出改进和发展的方向,以期为儿童药物临床试验工作提供参考。
The Beijing Capital Children’s Hospital Affiliated to Capital Medical University is the first drug clinical trial institution to be accredited for clinical trials of children’s medicines. At the same time, it is the institution that has the largest number of children’s drug clinical trials qualifications in China. As of May 2015, a total of 110 children’s drug clinical trials have been undertaken. The work has accumulated a wealth of experience in clinical trial management of children’s medicines, but there are also many problems: the number of clinical trials to undertake the project in the distribution of the number of non-uniform; clinical trials of drugs and uneven distribution of clinical trials of different professional quality of the completion of clinical trials Big difference This article starts with the status quo of drug clinical trials in our hospital, analyzes the existing problems and proposes the direction of improvement and development, with a view to providing reference for clinical trials of children’s medicines.