浅析临床试验保险中的问题及对策  

Discussion on the Issues and Countermeasures in Clinical Trial Insurance

作　　者：彭朋[1] 元唯安[1] 胡薏慧[1] 汤洁[1] 朱蕾蕾[1] 贺敏[1] 蒋健[1] PENG Peng YUAN Weian HU Yihui TANG Jie ZHU Leilei HE Min JIANG Jian(National Drug Clinical Trial Institution, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China,)

机构地区：[1]上海中医药大学附属曙光医院国家药物临床试验机构,上海201203

出　　处：《中国医学伦理学》2017年第3期328-330,335,共4页Chinese Medical Ethics

基　　金：国家"重大新药创制"科技重大专项创新药物研究开发技术平台建设(课题编号:2012ZX09303009-001);上海市中医药事业发展三年行动计划项目(ZY3-CCCX-2-1003)

摘　　要：通过对我国临床试验保险现状、保障范围争议的分析,认为国内临床试验的参保率总体偏低,申办者、临床试验机构、研究者、保险公司的重视程度不一。因此,我国应提高对药物/医疗器械临床试验风险认识,要全面推行临床试验保险,必须经过政府部门、伦理委员会、申办者、临床试验机构、研究者、保险公司等各方共同努力。Through analyzing the current situation and coverage controversy of Chinese clinical trial insurance,this paper stated that the attending insurance rate in domestic clinical trials was entirely low.The sponsors,clinical trial institutions,investigators and insurance companies paid attention of different levels to clinical trial insurance.Therefore,the risk awareness of drug/medical device clinical trials should be enhanced.It is necessary to give impetus to clinical trial insurance system,during which all parties need to make a joint effort including government departments,ethics committees,sponsors,clinical trial institutions,investigators and insurance companies.

关 键 词：临床试验 保险 风险控制 

分 类 号：R-052[医药卫生]