Abstract：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.
冯钰, 陈仲林, 卢芳, 李榕. 从风险管控的角度研究我院临床试验投保与理赔现状[J]. 中国药学杂志, 2022, 57(15): 1297-1301.
FENG Yu, CHEN Zhong-lin, LU Fang, LI Rong. Research on Status Quo of Clinical Trials Insurance and Claim Settlement in Hospital from the Perspective of Risk Control. Chinese Pharmaceutical Journal, 2022, 57(15): 1297-1301.
ZHANG N, WANG Y M, CHEN Z. Considerations on phase-dependent CMC requirements for innovative drugs[J]. Chin Pharm J(中国药学杂志),2014,49(17): 1565-1568.
[2]
NMPA. Announcement of NMPA and NHC on The Issuance of Good Clinical Practice[EB/OL]. (2020-04-26). https://www. nmpa. gov. cn/zhuanti/ypzhcglbf/ypzhcglbfzhcwj/202004 26162401243. html.
[3]
PENG P, YUAN W A, HU Y H, et al. Discussion on the issues and countermeasures in clinical trial insurance[J]. Chin Med Eth(中国医学伦理学), 2017,30(3):328-335.
[4]
SUN J, XUE W Y, CAO L J. Investigation and analysis of insurance for volunteers in clinical trials of drugs in China[J]. Clin Med J(临床药物治疗杂志), 2019,17(3):82-85.
[5]
FU Z Y, LIU X H, ZHAO S H, et al. Investigation on insurance and claim of adverse events in clinical trials of antitumor drugs[J]. Chin J Clin Pharmacol(中国临床药理学杂志), 2021,37(15):2082-2085.
[6]
ZHANG L, KANG C Q, SHU H, et al. Study on damage compensation for subjects in drugs clinical trials[J]. Chin Med Eth(中国医学伦理学),2015,28(5):758-761.
[7]
CAO Y, TANG L, LIU M B, et al. Damage management of subjects in drug clinical trials Guangdong consensus(2020)[J]. Pharm Today(今日药学),2020,30(7): 433-441.
[8]
WANG C Q. Current situation and counter measures of insurance in clinical trials[D]. Guangzhou: Jinan University,2014.
[9]
ZHENG Q S, XU Z Y. Status quo of clinical trials insurance practice at home and abroad[J]. Med Philos(医学与哲学),2020,41(4):56-59,80.
[10]
DONG X F, FAN Z. Clinical trial liability insurance covers No subject but institute[J]. Chin J Clin Pharmacol(中国临床药理学杂志),2015,31(24):2474-2476.
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