搭建药物临床试验登记与信息公示平台以促进保障受试者权益  

Building the platform for registry and publicity of drug clinical trials to safeguard the interests of human subject

作　　者：王玉珠[1] 王鹏[1] 史继峰[1] 刘晓钰[1] 黄钦[1] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国新药杂志》2015年第5期496-498,共3页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项(2011ZX09304-01)

摘　　要：临床试验登记和关键信息公示是《赫尔辛基宣言》的伦理要求,也是研究人员和监管部门的科学和道义责任。国家食品药品监督管理总局2013年发布通知要求在我国境内开展的所有药物临床试验在药品审评中心搭建的"药物临床试验登记与信息公示平台"(网址:www.chinadrugtrials.org.cn)进行登记和信息公示,以促进保障受试者权益。本文从伦理、科学和道义等层面详细阐述药物临床试验信息公示的重大和深远意义,以促进和指导该项工作的开展。The registry of clinical trials and publicity of pivotal information are to fulfill not only the ethical requirements of the ＂Helsinki Declaration＂,but also the science and moral obligations of the researchers and regulatory agencies. The China Food and Drug Administration issued the notice in 2013 to require that all the clinical trials conducted in China should be registered and made public of key information on the Platform for Registry and Publicity of Drug Clinical Trials（ website： www. chinadrugtrials. org. cn） established by Center for Drug Evaluation to promote and protect the interests of human subject. The publicity significance of clinical trials in respect of ethics,science and morality were introduced in this paper to facilitate and guide the evolving of this work.

关 键 词：药物临床试验 登记 公示 受试者 权益 

分 类 号：R95[医药卫生—药学]