眼科新药临床试验中安慰剂对照的伦理审查问题探讨  

Ethical Review on Placebo Control in Ophthalmic New Drug Clinical Trials

作　　者：江一峰[1] 马磊[1] 张舒雅[1] 宫尔君 祝延红[1] 

机构地区：[1]上海市第一人民医院医学伦理委员会,上海200080

出　　处：《中国医学伦理学》2014年第2期189-190,共2页Chinese Medical Ethics

基　　金："重大新药创制"科技重大专项项目(项目编号:2011ZX09302-007);上海市卫生局科研课题面上项目(项目编号:20134346)

摘　　要：一些研发中的眼科新药在进行临床试验时常常使用安慰剂作为对照。在眼科新药的临床试验中,使用安慰剂必须遵循两条原则,一是安慰剂的使用不能造成受试者视力不可逆或永久性的损害,二是研究者必须做好安慰剂的风险管控并将安慰剂的风险向受试者完全披露。对于安慰剂使用的伦理审查,应该从标准治疗的效果、安慰剂的风险、研究方案中风险的管理和知情同意书中风险的告知这几个方面进行综合评估。In China , some ophthalmic new drug clinical trials used placebo as control .Two principles should be con-sidered in ethical review when placebo was used in these ophthalmic new drug clinical trials .Firstly, using placebo couldn＆#39;t lead to irreversible or permanent vision loss .Secondly , there should be proper risk management in protocol and risk dis-closure in consent process .There are several important factors , including effects of standard treatment , risks of using pla-cebo, risk management in protocol and risk information in informed consent form , which should be used to assess the ra-tionality of placebo in ethical review .

关 键 词：医改伦理创新 安慰剂 眼科 新药 临床试验 伦理审查 

分 类 号：R-052[医药卫生]