从风险管控的角度研究我院临床试验投保与理赔现状

Research on Status Quo of Clinical Trials Insurance and Claim Settlement in Hospital from the Perspective of Risk Control

目的 对医院临床试验投保与理赔现状进行调研,从风险管控的角度挖掘问题,并提出改进建议。方法 筛选我院自2019年1月1日启动,至2021年10月30日仍在研的注册类临床试验,分析临床试验保险的覆盖率、实际理赔率、被保人和险种等内容。结果 共计126项在研注册类临床试验的整体投保率在90%以上,且国内企业投保率高于国外企业;83.7%的申办者为唯一被保险人;发生与研究药物/器械相关的不良事件(adverse event, AE)平均赔付率0.14%,发生与研究药物/器械相关的严重不良事件(serious adverse event, SAE)平均赔付率6.62%;保险险种主要是药物和器械临床试验责任保险。结论 目前临床试验保险投保率有所提高,但赔付率总体较低,且保险险种缺乏针对性,侧重于分担申办者风险,一定程度上提升了受试者权益保障,但对研究机构和研究者的保护价值较为薄弱。因此,建议进一步明确临床试验保险赔付原则,开辟理赔绿色通道,推行临床试验专用保险政策,注重对研究机构和研究者的权益保护。通过控制临床试验全过程存在的风险,保障受试者-研究者-申办者整体环节的权益。

OBJECTIVE To investigate the situation of the hospital clinical research insurance and claim settlement, and find out the existing problems from the perspective of risk control, so as to put forward improvement suggestions. METHODS A total of 126 registered clinical trials under research were investigated from January 1, 2019 to October 30, 2021, and the insurance coverage, actual claim ratio, insured and types of insurance were analyzed. RESULTS The overall insurance rate of 126 registered clinical trials under research is more than 90%, and the insurance rate of domestic enterprises is higher than that of foreign enterprises;83.7% serious adverse event of the sponsors are the only insured;The average compensation ratio of(adverse event, AE) is 0.14%, and that of(serious Adverse Event, SAE) is 6.62%. The main types of insurance are drug and device clinical trial liability insurance. CONCLUSION At present, the coverage rate of clinical trial insurance has been improved, but the compensation rate is generally low, and the types of insurance are lack of pertinence. They focus on sharing the risk of the sponsor, and improves the protection of the rights and benefits of subjects to a certain extent. But, the protection value of the current insurance for research institutions and researchers is relatively weak. Therefore, it is suggested to further clarify the compensation principle of the clinical trial insurance, open up a green channel for claims settlement, implement the special insurance policy for clinical trials, and pay attention to the protection of the rights and interests of research institutions and researchers. By controlling the risks in the whole process of clinical trial, the rights and interests of the link of subject-researcher-sponsor are guaranteed.