摘要
国际多中心药物临床试验既包括新药上市前的临床试验,也包括对药物上市使用后所做的进一步研究,以证实或揭示试验用药物的作用,不良反应及其吸收、分布、代谢和排泄的规律。其发展折射着全球化进程在医药卫生领域的快速发展,目前我国的国际多中心药物临床试验日渐增多,伦理审查中出现的伦理冲突也愈发明显,主要表现在伦理标准、试验参与各方的利益、本地化和国际性、审查的质量差异、试验方法与伦理原则等方面。对此,应提高各中心伦理委员会的素质和能力;注重协调各中心利益;加强中心之间的有效沟通。
International multi-center clinical trials of drugs,including both pre-clinical trials of new drugs and further study,are expected to confirm or reveal the effects of the drug,adverse reactions,absorption,distribution,metabolism and excretion.With the increasing of international multi-center clinical trials of drugs,the number of ethical conflicts in ethical review also increases apparently,mainly in ethical standards,the interests of all parties involved in the tests,the quality differences,the conflicts between localization and international,test methods and ethical principles.In this regard,we should enhance the quality and ability of central ethics committee,pay attention to the coordination of the ethics committee interest,and strengthen effective communication between ethics committees.
出处
《医学与哲学（A）》
北大核心
2014年第7期23-25,共3页
Medicine & Philosophy:Humanistic & Social Medicine Edition
基金
天津市哲学社会科学研究规划课题"和谐社会视域中的医疗公平问题研究"
项目编号:TJZX11-004
关键词
国际多中心研究
药物临床试验
伦理审查
international multi-center research
clinical trial of drug
ethical review
