| 摘要: |
| 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。在近八年的工作中，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。本文从我院机构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方向，以期为儿童药物临床试验工作提供参考。 |
| 关键词: 儿童 机构 药物临床试验 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2016.04.004 |
|
| 基金项目:国家卫生和计划生育委员会2014年委托课题——儿童临床用药综合评价体系试点研究 |
|
| The Current Situation and Existing Problems of Drug Clinical Trials for Children in Our Hospital |
| Zhang Yanju, Wang Xiaoling |
| (Children’s Hospital, Capital University of Medical Sciences, Beijing 100045, China) |
| Abstract: |
| The drug clinical trial institution of Beijing children’s hospital is the first one approved the qualifications of drug clinical trial of children, has the maximum number of drug clinical trial of children at present. As of May 2015, a total of 110 items we have undertaken. During nearly eight years, we have accumulated rich experience, but also have many problems: the mumber, category and the completed quality of trials between various departments are different. Based on the current situation of drug clinical trials, we analysis the existing problems and put forward the improvement and development direction, so as to provide reference for drug clinical trials of children. |
| Key words: Children Institution Drug clinical trial |
