The National Institutes of Health (NIH) launched the Rapid Acceleration of Diagnostics (RADx ^SM ) Tech initiative to support the development and commercialization of novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) point-of-care test devices. The primary objective of the Clinical Studies Core (CSC) was to perform SARS-CoV-2 device studies involving diverse populations and settings. Within a few months, the infrastructure for clinical studies was developed, including a master protocol, digital study platform, data management system, single IRB, and multi-site partnerships. Data from some studies are being used to support Emergency Use Authorization of novel SARS-CoV-2 test devices. The CSC reduced the typical time and cost of developing medical devices and highlighted the impactful role of academic and NIH partnership in addressing public health needs at a rapid pace during a global pandemic. The structure, deployment, and lessons learned from this experience are widely applicable to future in vitro diagnostic device clinical studies.

中文翻译：

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RADx Tech 临床研究核心：基于学术的临床研究模型


美国国立卫生研究院 (NIH) 启动了快速诊断加速 (RADx ^SM ) 技术计划，以支持新型严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 护理点测试设备的开发和商业化。临床研究核心 (CSC) 的主要目标是开展涉及不同人群和环境的 SARS-CoV-2 设备研究。几个月内，临床研究的基础设施就开发出来了，包括主协议、数字研究平台、数据管理系统、单一IRB和多站点合作伙伴关系。一些研究的数据正用于支持新型 SARS-CoV-2 测试设备的紧急使用授权。 CSC 减少了开发医疗设备的典型时间和成本，并强调了学术界和 NIH 合作伙伴关系在全球大流行期间快速满足公共卫生需求方面的重要作用。这一经验的结构、部署和经验教训广泛适用于未来的体外诊断设备临床研究。