| 摘要: |
| 通过了解我国儿童药物临床试验的现状，分析儿童药物试验开展困难的原因，借鉴其他国家有关儿童药物临床试验的伦理规范，结合我国《儿科人群药物临床试验技术指导原则》（征求意见稿），讨论我院在开展儿童临床药物试验伦理审查工作的经验与体会。 |
| 关键词: 儿童 药物临床试验 伦理审查 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2016.02.004 |
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| 基金项目: |
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| Children’s Medicines Present Situation and the Practice of Ethical Review of Clinical Trials |
| Lu Xiaotong, Shi Min, Zhang Chun, Liu Yan, Shi Junfeng |
| (Xinhua Hospital of Shanghai Jiaotong University School of Medicine, Shanghai 200092, China) |
| Abstract: |
| Investigation of present situation about children’s drug clinical experiments and practice of ethic examinations, to investigate the present situation and analyze the obstruction impeding the implement of clinical experiment. Drawing lessons from other countries standards about the children’s ethic clinical experiment, combining with “The guide of drug clinical experiment technology in children”, we discussed the experience about the children’s ethic examination in drug clinical experiment. |
| Key words: Children Drug clinical experiment Ethic examination |
