摘要
研究者发起的临床研究(IIT)通常使用已上市的药品、医疗器械或诊断试剂等进行新用途、新适应证和新组合的探索,研究本身具有探索性和创新性,也必然伴随一定的未知风险。“临床试验责任保险”是降低临床研究潜在损害所导致的赔付风险和财务负担的一种方式。为了解国内IIT项目研究者和管理者对该保险的认知状况,本研究通过网络问卷方式对来自25个省份医疗机构的201位受访者进行调研,分别了解其对受试者损害赔偿问题、临床保险单的内容、临床保险的额度、保单的免除范围、保险的流程培训等方面的认知情况。从调查结果可见,目前国内临床研究相关人员对于IIT项目购买临床试验责任保险的意义和如何有效通过保险来进行损害赔偿风险防控,对保险额度和期限、赔付比例的把关,对保险理赔流程的了解等方面有较大提高空间。
Investigator-initiated clinical studies often use marketed drugs,medical devices,or diagnostic reagents to explore new uses,indications,and combinations,which are inherently exploratory and innovative,and inevitably come with certain unknown risks.“Clinical trial liability insurance”is a way to reduce the risk of payout and financial burden caused by potential damages in clinical research.In order to understand the knowledge of domestic IIT researchers and managers about this insurance,the author conducted a survey by means of an online questionnaire among 201 respondents from medical institutions in 25 provinces to understand their knowledge about subject damage compensation,the content of clinical insurance policies,the amount of clinical insurance,the scope of policy exemptions,and the training of the insurance process,respectively.From the survey results,it can be seen that there is much room for improvement in the meaning of purchasing clinical liability insurance for IT projects and how to effectively prevent and control the risk of damage compensation through insurance,the need to strengthen the gatekeeper of insurance amount and duration,and the payout ratio,as well as the understanding of the insurance claim process in China.
作者
曹烨
林珍
李彬彬
刘亚卿
符忠
CAO Ye;LIN Zhen;LI Bin-bin;LIU Ya-qing;FU Zhong(Department of Clinical Research,Cancer Hospital of Sun Yat-sen University,Guangzhou 510060,China;Office of Clinical Research,The Second Hospital of Fujian Medical University,Quanzhou 362000,China;Asia Pacific Property and Casualty Insurance Company Limited Beijing Branch,Beijing 100077,China;Shanghai Pudong Wuxin Insurance Brokerage Co.,Ltd.,Shanghai 201203,China;Guangdong Junxin Jinglun Junhou Law Firm,Guangzhou 510000,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2024年第3期274-278,共5页
Chinese Journal of New Drugs
关键词
研究者发起的临床研究
临床试验责任保险
认知调研
investigator-initiated clinical trials
clinical trial liability insurance
awareness survey
