在COVID-19临床试验中与VA合作的经验教训
Krissa Caroff1, Victoria J Davey1, Miriam Smyth1
1Office of Research and Development, Department of Veterans Affairs, Washington, DC.
概括
美国退伍军人事务部 (VA) 利用其基础设施进行COVID-19试验,加强合作伙伴关系并开发临床研究协调和效率的最佳实践.
科学领域:
- 临床试验 临床试验
- 公共卫生 公共卫生
- 医疗保健服务研究 医疗服务研究
背景情况:
- 美国退伍军人事务部 (VA) 研究和开发办公室 (ORD) 管理着一家大型临床试验企业.
- 从历史上看,外部合作伙伴关系是有限的,但COVID-19大流行突显了VA的价值,因为它拥有广泛的医疗保健系统,多样化的患者群体和临床试验专业知识.
研究的目的:
- 描述VA的经验和从参与大规模COVID-19治疗和疫苗试验中吸取的经验教训.
- 确定开展多站点临床研究的挑战和解决方案,特别是在需要快速协调的流行病条件下.
主要方法:
- 利用现有的VA基础设施参与7个主要的COVID-19试验.
- 开发多站点研究的集中指导和协调策略.
- 记录与现场能力,研究管理,教育,审查流程,研究设计,合同和沟通相关的挑战和解决方案.
主要成果:
- 成功参与了7项大规模的COVID-19治疗和疫苗试验.
- 通过外部合作伙伴关系获得了多站点临床研究实践的经验.
- 确定了改善研究启动时间和整体协调的关键领域.
结论:
- 华盛顿特区在COVID-19试验中的参与为研究和监管批准做出了重大贡献.
- 合作伙伴关系增强了外部团体对VA的理解,并为多站点研究提供了宝贵的经验.
- 这些努力加强了VA为更广泛的科学和临床社区服务的能力.
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