一个的拥抱? 保险和全球临床试验
Janelle Winters1,2,3
1Humanitarian and Conflict Response Institute, Ellen Wilkinson Building, School of Arts, Languages and Cultures, University of Manchester, Manchester, M15 6JA, UK. janelle.winters@history.ox.ac.uk.
Health research policy and systems
|February 10, 2026
概括
临床试验保险成本和复杂的要求造成了显著的延迟,特别是在低收入和中等收入国家 (LMICs) 的多国研究中. 需要由LMIC决策者领导的改革来简化这些保险程序,以应对未来的健康紧急情况.
科学领域:
- 卫生政策 卫生政策
- 临床试验管理 临床试验管理
- 全球卫生安全 全球卫生安全
背景情况:
- 监管障碍阻碍了临床试验的批准,特别是多国学术试验以及低收入和中等收入国家 (LMICs) 的学术试验.
- 临床试验保险是临床试验监督的关键组成部分,在监管效率和道德框架的分析中基本被忽视.
- 现有的文献经常使用比喻,比如"猎的拥抱"来描述监管障碍,但未能详细说明保险的具体影响.
研究的目的:
- 分析过去50年来临床试验赔偿机制的演变.
- 调查多国临床研究中的程序障碍,利用COVID-19大流行和特定的案例研究.
- 确定保险要求如何影响LMIC试验场地启动.
主要方法:
- 对临床试验赔偿机制的结构化文献综述.
- 牛津大学"COPCOV"试验的案例研究分析,包括对65多个利益相关者采访的专题分析.
- 检查保险文件和利益相关者的沟通.
主要成果:
- 对COPCOV试验的补充再保险超过了11万英,并导致国家批准延迟了多达9个月.
- 赞助商提到声誉损害的担忧是昂贵的保险政策的理由.
- 金融风险管理框架和当地保险要求的扩大,为在LMIC中启动试验站点创造了巨大的障碍.
结论:
- 提出了两个改革途径:程序和系统,以解决临床试验保险的障碍.
- 改革应该由LMIC的政策制定者带头进行,以确保相关性和有效性.
- 简化保险程序对于及时获得有关全球卫生紧急情况期间有效对策的证据至关重要.
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