The RADx Tech Clinical Studies Core: A Model for Academic Based Clinical Studies
作者： Oliver Brand , Jennifer Frediani , Nisha Fahey , Chad Achenbach , Bryan Buchholz
DOI: 10.1109/OJEMB.2021.3070830
关键词:
摘要: The National Institutes of Health (NIH) launched the Rapid Acceleration Diagnostics (RADxSM) Tech initiative to support development and commercialization novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) point-of-care test devices. primary objective Clinical Studies Core (CSC) was perform SARS-CoV-2 device studies involving diverse populations settings. Within a few months, infrastructure for clinical developed, including master protocol, digital study platform, data management system, single IRB, multi-site partnerships. Data from some are being used Emergency Use Authorization CSC reduced typical time cost developing medical devices highlighted impactful role academic NIH partnership in addressing public health needs at rapid pace during global pandemic. structure, deployment, lessons learned this experience widely applicable future vitro diagnostic studies.
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