浅析临床试验保险中的问题及对策.pdfVIP

网址与投稿:http://yxllx. xjtu. edu. cn 浅析临床试验保险中的问题及对策* 彭朋，元唯安，胡惹慧，汤洁，朱蕾蕾，贺敏，蒋健* * (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 ， h凹yp_2∞7@ hotmai l. com) 〔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、1)各床试验机构、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。 〔关键词〕临床试验;保险;风险控制 〔中图分类号)R -052 (文献标识码)A 〔文章编号)1001 -8565(2017}03 -0328 -03 DOI:10.12026/j. issn.1001 -8565.2017.03.17 Discussion on the Issues and Countermeasures in Clinical Trial Insurance PENG Peng , YUAN Weiαn ， HU Yihui , TANG Jie , ZHU Leilei , HE Min , JIANG Jian (National Drug Clinical Trial In.s titution , Shuguang Hospital 相比ted to Shanghαi University 0/ Traditional Chinese Medici肘， Shanghαi 201203 , China , E-mail :加叫p_2007@ hotmail. com) Abstract :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 druglmedical device clinical trials should be enhanced. It is necessary to give im- petus 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. Key words: Clinical Trial; Insurance; Risk Control 临床试验是指所有在人体(病人或健康志愿 根据《国家药品不良反应监测年度报告(2015 年n所提供的 1999-2015 年全国药品 ADRlAE 者)进行药物或医疗器械的系统性研究，其目的是 收集试验药物或医疗器械的有效性和安全性的数 报告数量，这段时间内我国的药品不良反