Gibson, Laura LFahey, Nisha M.Hafer, NathanielBroach, JohnBarton, Bruce ALemon, Stephenie CBlodgett, AllisonMcManus, David D2022-08-232022-08-232021-04-282021-05-05<p>L. L. Gibson et al., "The RADx Tech Clinical Studies Core: A Model for Academic Based Clinical Studies," in IEEE Open Journal of Engineering in Medicine and Biology, vol. 2, pp. 152-157, 2021, doi: 10.1109/OJEMB.2021.3070830. <a href="https://doi.org/10.1109/OJEMB.2021.3070830" target="_blank" title="view article on publisher's site">View article on publisher's site</a></p>10.1109/OJEMB.2021.307083034192287https://hdl.handle.net/20.500.14038/41794<p>Full author list omitted for brevity. For the full list of authors, see article.</p>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.en-USThis work is licensed under a Creative Commons Attribution 4.0 License. For more information, see https://creativecommons.org/licenses/by/4.0/http://creativecommons.org/licenses/by/4.0/SARS-CoV-2COVID-19in vitro diagnosticspoint-of-care testingrapid acceleration of diagnosticsUMCCTS fundingBiomedical Engineering and BioengineeringDiagnosisHealth and Medical AdministrationInfectious DiseaseTranslational Medical ResearchVirus DiseasesJournal Articlehttps://escholarship.umassmed.edu/cgi/viewcontent.cgi?article=5624&amp;context=oapubs&amp;unstamped=1https://escholarship.umassmed.edu/oapubs/459422798775oapubs/4594