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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
The RADx Tech Clinical Studies Core: A Model for Academic Based Clinical Studies
IEEE Open Journal of Engineering in Medicine and Biology, Volume 2, Article 9418528, Year 2021
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Description
The National Institutes of Health (NIH) launched the Rapid Acceleration of Diagnostics (RADxSM) 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. © 2020 IEEE.
Authors & Co-Authors
Gibson, Laura L.
United States, Worcester
University of Massachusetts Chan Medical School
Murphy, Robert L.
United States, Chicago
Northwestern University Feinberg School of Medicine
Achenbach, Chad J.
United States, Chicago
Northwestern University Feinberg School of Medicine
Vos, Miriam B.
United States, Atlanta
Emory University School of Medicine
Lam, Wilbur Aaron
United States, Atlanta
Emory University School of Medicine
Martin, Greg S.
United States, Atlanta
Emory University School of Medicine
Manabe, Yukari C.
United States, Baltimore
Johns Hopkins School of Medicine
Robinson, Matthew L.
United States, Baltimore
Johns Hopkins School of Medicine
Barton, Bruce A.
United States, Worcester
University of Massachusetts Chan Medical School
Statistics
Citations: 9
Authors: 9
Affiliations: 9
Identifiers
Doi:
10.1109/OJEMB.2021.3070830
ISSN:
26441276
Research Areas
Covid