The RADx Tech Clinical Studies Core: A Model for Academic Based Clinical Studies
Authors
Gibson, Laura L.Fahey, Nisha M.
Hafer, Nathaniel
Broach, John P.
Barton, Bruce A.
Lemon, Stephenie C.
Blodgett, Allison
McManus, David D.
UMass Chan Affiliations
Prevention Research CenterDepartment of Medicine, Division of Cardiovascular Medicine
Graduate School of Nursing
Department of Population and Quantitative Health Sciences
Department of Emergency Medicine
UMass Center for Clinical and Translational Science
Department of Pediatrics
Department of Medicine, Division of Infectious Diseases and Immunology
Document Type
Journal ArticlePublication Date
2021-04-28Keywords
SARS-CoV-2COVID-19
in vitro diagnostics
point-of-care testing
rapid acceleration of diagnostics
UMCCTS funding
Biomedical Engineering and Bioengineering
Diagnosis
Health and Medical Administration
Infectious Disease
Translational Medical Research
Virus Diseases
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Show full item recordAbstract
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.Source
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. View article on publisher's site
DOI
10.1109/OJEMB.2021.3070830Permanent Link to this Item
http://hdl.handle.net/20.500.14038/41794PubMed ID
34192287Notes
Full author list omitted for brevity. For the full list of authors, see article.
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This work is licensed under a Creative Commons Attribution 4.0 License. For more information, see https://creativecommons.org/licenses/by/4.0/Distribution License
http://creativecommons.org/licenses/by/4.0/ae974a485f413a2113503eed53cd6c53
10.1109/OJEMB.2021.3070830
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