首页|我国临床试验保险使用情况的调查与分析

我国临床试验保险使用情况的调查与分析

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目的:通过调研分析目前国内外临床试验保险的实施情况,为我国临床试验保险的发展提出建议。方法:通过文献调研与问卷调查相结合的方式,对临床试验中各相关主体展开调研,并运用描述性统计方法对调研结果进行分析。结果:共收回有效调查问卷373份,其中68。4%的调查对象所在单位涉及受试者损害的赔偿问题。在材料齐全的情况下,保险公司赔偿时效一般在30个工作日内,约70%可以在60个工作日内完成,90%的调查对象对保险公司完成赔案的处理时效基本满意。对保险公司使用"五分法"提出的赔偿比例,78。6%的调查对象基本满意。五分量表作为需求程度的评估形式可对临床试验保险相关必要性进行量化评估,约80%的调查对象认为临床研究购买保险非常重要。结论:本文根据调研结果剖析临床试验保险目前存在的问题并进一步提出解决策略,通过完善我国临床试验保险制度、建立合理的赔偿标准、优化理赔流程等措施进一步规范商业保险临床试验责任险的行业行为,减少受试者参与临床试验的负面印象,提高受试者参与临床试验的积极性,促进临床试验持续健康发展。
An investigation of commercial insurance implementation in clinical trials in China
Objective:To investigate the current implementation of commercial insurance in clinical trials globally,and provide data support for the development of clinical trials insurance in China.Methods:The study was conducted based on literature survey and questionnaires from subjects involved in clinical trials.Results were analyzed using descriptive statistical methods.Results:A total of 373 questionnaires were completed finally.68.4% institutions were involved in compensation issues related to subject injury during clinical trials.If all necessary materials were provided,insurance companies completed compensation within 30 working days in general,with about 70% within 60 working days.90% of the subjects were satisfied with the insurance company's processing time limit for completing the compensation case.78.6% of the subjects were satisfied with the compensation ratio proposed by insurance companies using the"five-point method".Based on the"five-point scale"for assessment on the necessity of clinical trial insurance,80% of the subjects believed that it was very important to purchase insurance for clinical trial research.Conclusion:By improving clinical trial insurance system in China,establishing reasonable compensation standards,optimizing claims process and other measures,the commercial insurance in clinical trials can be further standardized.Thus,sustainable and healthy development of clinical trials can be promoted with reduced negative impression of clinical trials participates and improved enthusiasm.

clinical trialinsurancesubjectssurveys

王佳庆、冯宝玉、许淑红、方朝晖、白彩珍、王维聪、徐春敏、李姝雅

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首都医科大学附属北京天坛医院临床试验中心,北京100070

临床试验 保险 受试者 问卷调研

2024

中国新药杂志
中国医药科技出版社 中国医药集团总公司 中国药学会

中国新药杂志

CSTPCD北大核心
影响因子:1.039
ISSN:1003-3734
年,卷(期):2024.33(24)