摘要
目前我国儿童药物临床试验的开展存在儿科试验机构缺乏,研究者缺少专业性培训,试验方案不符合儿童受试者安全保障的要求,知情同意流于形式,不良反应的隐瞒不报以及伦理审查趋于形式化等安全隐患。因此必须大力扶持儿童药物临床试验机构,加强研究者的专业培训和伦理素质,试验方案应当针对儿童受试者的安全保障进行特殊设计,采取措施保障儿童及其法定监护人知情同意的实现,完善不良事件的监测和汇报程序,强化对儿童药物临床试验的伦理审查以及建立和完善相关立法,从而保证儿童受试者得到较全面的安全保障。
At present,there are many safety loopholes in children clinical trials in China,including the lack of pediatric trial institutions,the insufficient professional training for researchers and the insecurity of test programs,etc. Moreover,the informed consents,the ethical reviews and the reporting systems tend to become a mere formality. Thus,it is important to support pediatric trial institutions,to strengthen professional training and to design specific test programs for children. Furthermore,measures should be taken to guarantee the informed consent for children and their legal guardians,to improve the monitoring and reporting systems of adverse reactions,and to perfect ethical reviews including the relevant legislation in order to establish a comprehensive safety assurance for children participants.
出处
《中国医学伦理学》
2015年第6期847-850,共4页
Chinese Medical Ethics
关键词
药物临床试验
儿童受试者
安全保障
Drug Clinical Trial
Children Participants
Security Assurance
