儿童药物临床试验的现状与伦理审查实践  

Present Situation and Practice of Ethical Review in Children's Drug Clinical Experiments

作　　者：陆晓彤[1] 刘海涛[1] 施敏[1] 刘艳[1] 是俊凤[1] 

机构地区：[1]上海交通大学医学院附属新华医院,上海200092

出　　处：《儿科药学杂志》2016年第2期11-13,共3页Journal of Pediatric Pharmacy

摘　　要：通过了解我国儿童药物临床试验的现状,分析儿童药物临床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。To investigate present situation about children＇s drug clinical experiments and the practice of ethic review,analyze the obstruction impeding the implement of clinical experiment. Drawing lessons from other countries＇ standards about the children＇s drug clinical experiments,combining with＂The guide of drug clinical experiment technology in children＂,discussed the experience about the children＇s ethic review in drug clinical experiment.

关 键 词：儿童 药物临床试验 伦理审查 

分 类 号：R969.3[医药卫生—药理学]