在欧洲协调COVID-19平台试验
Jacques Demotes1, Victoria Charlotte Simensen2, Keiko Ueda3
1European Clinical Research Infrastructure Network, ECRIN, 30 Boulevard Saint-Jacques, Paris, 75014, France. jacques.demotes@ecrin.org.
Trials
|April 24, 2024
概括
欧盟资助的COVID-19平台试验采用了双重协调方法,包括试验协调委员会 (TCB) 和联合访问咨询机制 (JAAM),以加强合作和资源使用. 该模型正在扩展,以应对未来的流行病准备.
科学领域:
- * 临床试验管理
- * 流行病学和公共卫生
- * 传染病研究 传染病研究
背景情况:
- *协调针对COVID-19等传染病的大规模多站点平台试验,带来了重大后勤和运营挑战.
- * 调查人员,公共卫生机构和监管机构之间的有效合作对于高效的试验执行和快速反应至关重要.
研究的目的:
- *描述和评估欧盟资助的COVID-19平台试验的新型双重协调机制.
- *评估审判协调委员会 (TCB) 和联合访问咨询机制 (JAAM) 在促进合作和优化资源利用方面的效率.
- * 建立一个可持续的平台试验协调模型,适用于当前和未来的流行病准备工作.
主要方法:
- * 实施双重协调结构:试验协调委员会 (TCB) 进行利益相关者对话,联合访问咨询机制 (JAAM) 进行干预.
- * 开发一个适应性平台试验工具箱,以记录挑战和解决方案.
- *启动"队列和试验协调机制" (CoMeCT) 项目,以实现可持续性和扩展.
主要成果:
- *TCB和JAAM被证明是促进调查人员和公共卫生利益相关者之间的合作的有效工具.
- *已建立的协调机制优化了欧盟资助的适应性平台试验中的资源利用.
- *成功创建了一个适应性平台试验工具箱,巩固了关于试验协调的知识.
结论:
- *双重协调机制 (TCB和JAAM) 是管理欧盟资助的自适应平台试验的有效模式.
- * CoMeCT项目旨在确保这种协调模式的长期可持续性,并将其应用于其他传染病.
- * 这种方法为不同疾病领域的平台试验协调和未来的流行病准备计划提供了有价值的框架.
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