摘要
我国儿童药品短缺,超说明书用药情况未得到缓解,国家政策大力支持儿童药的研发,药物临床试验需求旺盛,处在良好的发展机遇。儿童生理、心理不成熟,认知水平较低,是临床试验中的弱势群体。伦理委员会需要结合儿童特点,对试验方案、知情同意过程及知情同意书进行审查,及时发现问题并予以纠正,避免将患儿置于不必要的风险中。通过对伦理审查中问题的总结分析,直面伦理挑战,协助研究者、申办方解决项目设计、进展中的问题,提高研究者的积极性;促进成立儿童药物临床试验联盟,定期拟定题目,召开专题讨论会,兼顾培养合格研究者和解决实际发生的问题。
The shortage of children's medicine and off-label medication in China have not been alleviated,national policy has strongly supported the research and development of children's medicine,so that the demand for clinical trials of drugs is strong and is in a good opportunity.Children is a vulnerable group in clinical trials for their physical and psychological immature,low level of cognition.The ethics committee should review the testing program,informed consent and its process in consideration of the characteristics of children,to promptly find out and correct the problems,so as to avoid placing children in unnecessary risk.Through summarizing and analyzing the problems in ethical review,this article is facing ethical challenges,assisting researchers and sponsors to solve problems in project design and progress,improving the enthusiasm of researchers;this article aims to promote the establishment of Children's Clinical Trial Alliance,regularly prepare topics and convene special seminar,which takes into account of training qualified researchers and solving actual problems at the same time.
作者
刘毅
朱彦丽
欧凌
张建民
LIU Yi;ZHU Yanli;OU Ling;ZHANG Jianmin(GCP Office,Children's Hospital,Capital Institute of Pediatrics,Beijing 100021,China;Dept.of Neurology,Children's Hospital,Capital Institute of Pediatrics,Beijing 100021,China)
出处
《中国医院用药评价与分析》
2019年第2期140-142,146,共4页
Evaluation and Analysis of Drug-use in Hospitals of China
基金
北京市属医学科研院所科技发展项目(No.PXM2018_026268_000004)
首都儿科研究所青年科研基金(No.QN-2016-16)
