暨南大学硕士学位论文
题名（中英对照）：临床试验保险的现状与对策
Current Situation and Counter measures of insurance in clinical trials 作者姓名：王超
指导教师姓名
及学位、职称：叶春玲博士教授
程国华博士教授
许重远博士教授
芝麻烧饼学科、专业名称：中药学
论文提交日期：2014年4月
论文答辩日期：2014年6月
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心形纪念币预约中文摘要
摘要：目的探索国内临床试验项目提供保险和国内临床试验保险条款的现状，完善保险中存在的问题，推动临床试验保险更好地实施。方法通过国内外对比和典型事件的分析，分析目前国内临床试验保险的现状；在此基础上，调查某药物临床试验中心2010-2013年在研的药物与医疗器械临床试验项目，并对4家保险公司的保险责任条款进行分析和比较，提出国内临床试验保险中存在的问题及对策。结果我国临床试验保险中仍存在一些问题：保险覆盖率低；保险险种不完善；大部分提供保险的国外申办方未提供中文保险说明书；没有权威机构和相关标准认定SAE与药物的相关性；国外申办方从国外保险公司购买保险不适用于国内的医疗现状；SAE赔付范围不明确，对于超过预期严重程度的预期SAE 是否应赔付没有明确的规定，为规避SAE产生的费用是否赔付没有被提及；伦理审查不充分，未对保险合同和保险内容进行审查等问题。这就需要临床试验的参与者强化购买保险的意识, 并
根据试验的具体情况选择合适的险种；伦理委员会深化对保险内容的审查；完善法律法规，以便于更好地保护受试者的权益。结论我国临床试验保险覆盖率与国外相比仍有一定差距，保险制度还没有健全。完善临床试验保险仍需要监管部门、伦理委员会、临床科室和保险公司等多方的共同努力。
绿萝花的功效与作用关键词：申办者临床试验受试者保险现状保险条款
ABSTRACT
Abstract: Objective To explore the current situation of insurances in clinical trials and the insurance clauses related to clinical trials in China; to improve the existing problems about insurance in clinical trials, and to push the implementation of insurances included in clinical trials. Methods T he current status of the domestic clinical trials insurance was analyzed through comparisons with other countries and analysis of the typical events. On this basis,new drugs and medical instruments clinical trials in research collected from Clinical Trials Center from 2010 to 2013 were investigated, and insurance clauses of four insurance companies were analyzed and then compared. Insurance related problems existing in clinical trial and relevant countermeasures were proposed. Results There are still some insurance related problems in clinical trial: the insurance coverage is low; type of insurance is imperfect; most of the foreign sponsors who provide insurances for clinical trials did n
ot provide insurance instruction in Chinese; there is no authoritative body or regulation to identify drug-related SAE; foreign sponsors usually purchase insurances from foreign insurance companies which could not apply to medical status in China; the scope of SAE compensation is not clear; there are no clear provisions referring to whether the SAEs above expected severity need to be reimbursed; whether the expenses produced by the avoiding of SAEs should be reimbursed is not mentioned; ethical review is not sufficient, not involving reviews on insurance contracts and insurance content，et al. Facing all the problems, clinical trial participants are required to enhance awareness of buying insurance and to choose the right insurance in accordance with the specific circumstances of clinical trials; also, Ethics Committees should deepen the review on the content of insurance; in order to better protect the interests of participants included in clinical trials, laws and regulations should be improved. Conclusion Nowadays, the coverage of insurance in Chinese clinical trial still falls behind in comparison with foreign countries, and insurance system in China also is not perfect. To optimize insurance situation in clinical trials calls for joint efforts from supervision departments, Ethics Committee, clinical departments and insurance companies, and so
on.
Key words: sponsors, clinical trials, participants, insurance status, insurance clauses
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