在新药与医疗器械临床试验中为受试者提供保险的调查与分析

Survey and analysis of insurance for volunteers in clinical trials of new drugs and medical instruments

目的分析与探讨新药与医疗器械临床试验中为受试者提供保险现状,推动新药与医疗器械临床试验为受试者提供保险实施与规范化。方法调查本院近2年的临床试验提供保险的状况。结果在本院进行的新药与医疗器械临床试验为受试者提供保险除了国外部分国际多中心临床试验外,大多数申办者没有按照国家法规为受试者提供保险,同时由于保险公司的险种制定不完整,出现严重不良事件不能很好鉴定,影响对受试者的赔偿。结论目前,由于许多新药临床试验没有为受试者提供保险,在试验中发生不良事件后,从而使越来越多的受试者与申办者﹑研究者的纠纷增加,应引起重视。

Objective To investigate the current situation of insurance support for volunteers in clinical trials of new drugs and medical instruments.Methods The data of insurance support for volunteers in clinical trials of new drugs and medical instruments in Peking University first hospital in recent two years were analyzed.Results The sponsors did not provide the insurance for volunteers according to the regulations of the state in most of clinical trails,except some global multi-center trials that damaged the rights of volunteers seriously.Moreover,types of insurance were incomplete that caused inadequate identification of serious adverse effect and inadequate compensation to related volunteers.Conclusion At present,more and more subjects and sponsor,investigator disputes increase after the adverse drug events because the sponsor did not provide insurance in the clinical trial for subjects so we should pay attention to it.