疫情期间快速进行的临床研究:经验教训和前进方向
Florence Ader1, Éloïse Aubret2, Nathalie Bergaud2
1Département des Maladies infectieuses et tropicales, Hospices Civils de Lyon F-69004 Lyon, France; Centre International de Recherche en Infectiologie (CIRI), Inserm 1111, Université Claude Bernard Lyon 1, CNRS, UMR5308, École Normale Supérieure de Lyon, Univ Lyon F-69007, France.
Infectious diseases now
|August 23, 2025
概括
全国新兴传染病运营研究网络 (OPEN-ReMIE) 成立,以加快疫情期间的医院临床研究. 它旨在加强国家和国际研究合作的准备和应对能力.
科学领域:
- 公共卫生
- 传染性疾病
- 临床研究网络
背景情况:
- COVID-19 疫情凸显了新兴传染病 (EID) 强有力的国家研究网络的需要.
- 现有结构需要加强,以有效地准备和应对具有流行病或流行病潜力的EID.
研究的目的:
- 建立和描述OPEN-ReMIE (EID运营研究网络) 国家网络.
- 概述其在流行病/流行病条件下加速医院临床研究的使命.
- 详细说明其在国家准备和国际合作中的作用.
主要方法:
- 该网络由法国2030资助,由国家研究机构 (ANR) 运营.
- 它具有在危机间和危机模式中可操作的治理结构.
- 六个工作包涵盖了监管事务,场地管理,方法,实验室资源,药物供应和培训/沟通.
主要成果:
- 作为一个国家准备工作组,
- 它是各种利益相关者的中心,包括赞助商,监管机构和患者协会.
- 该网络被整合到一个更大的欧洲联盟中,并与国际平台合作.
结论:
- 开放的ReMIE对于加强国家在EID临床研究的能力至关重要.
- 该网络旨在改善对未来的流行病或流行病威胁的准备和应对.
- 它的运营框架和协作方式是成功的关键.
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