浅谈临床试验中不良事件记录欠佳的原因和改善方法  

The reasons of poor recording of adverse events in clinical trials and methods for improvement

作　　者：雷翔[1] 郑文科[1] 王辉[1] 刘春香[1] 商洪才[1] 

机构地区：[1]天津中医药大学、天津中医药临床评价研究所,天津300193

出　　处：《中国新药杂志》2014年第11期1260-1263,共4页Chinese Journal of New Drugs

基　　金：国家十二五“重大新药创制”科技重大专项(2011ZX09304-08);教育部新世纪优秀人才计划(NCET-09-0900);天津市“131”创新性人才培养工程

摘　　要：通过对目前我国临床试验中不良事件记录率较低,临床研究文献中安全性报告不足的原因进行分析,针对研究者、申办者对不良事件的概念不清、记录不良事件的意识不强,缺乏相应的监督检查机制等原因,提出在医学教育和临床试验开展前的培训中加强相关概念和意义的教育,加强伦理委员会对不良事件监查的职责,设置临床不良事件监查组织等相应措施,以期提高临床研究对安全性的重视,保证受试者权益,提高患者用药安全。Through analyzing the reasons of the low record rate of adverse events in clinical trials and the lack of good safety reports in clinical studies literature, it was found that these phenomena were caused by lack of clear concept of adverse events and low awareness of the necessity of recording adverse events in the researchers and sponsors as well as lack of appropriate supervision and inspection mechanism and other reasons. The authors put forward the following measures to improve the situation： education about concepts and means of adverse events should be strengthened in medical education and training courses prior to clinical trials, ethics committees take more duties on inspection of adverse events, and clinical adverse events monitoring groups should be set up. It is hoped that more attention is paid by clinical researchers to the importance of safety, the rights and interests of the subjects are ensured, and the medication safety are improved through implement of these measures.

关 键 词：临床试验 不良事件 伦理委员会 监查组织 药物安全 

分 类 号：R969[医药卫生—药理学]