药物临床试验损害赔偿案例分析及管理思考

Case analysis and management of research-related injury compensation of drug clinical trials

目的从研究中心层面针对药物临床试验损害的预防和处理措施方面提出建议,增加对受试者权益的保护。方法分析医院发生具有代表性的2例药物临床试验损害赔偿案例的始末,针对研究中心项目管理提出建议。结果通过审查知情同意书和临床试验责任保险、积极参与损害处理并督促执行、关注安全性信息并评估临床试验风险程度等措施,伦理委员会、临床试验机构和研究者可在保护受试者的权益上发挥更多主动的作用。结论研究中心通过增加对临床试验损害的预防和处理措施,减小临床试验风险,增加对受试者权益的保护。

Objective To propose suggestions on the prevention and treatment measures of drug clinical trial research-related injury from the research center perspective,and improve the protection of the rights of human subjects.Methods Analyze three representative cases of drug clinical trial research-related injury compensation in a hospital,and put forward suggestions for the project management of the research center.Results By reviewing informed consent forms and clinical trial liability insurance,actively participating in research-related injury treatment and implementation supervision,paying attention to safety information and risk monitoring,ethics committees,clinical trial institutions and investigators can play more proactive roles in protecting the rights and interests of human subjects.Conclusions The research center could better control the risks of clinical trials and improve the protection of human subjects by strengthening the prevention and treatment measures for clinical trial research-related injury.