The RADx Tech Clinical Studies Core: A Model for Academic Based Clinical Studies

The RADx Tech Clinical Studies Core: A Model for Academic Based Clinical Studies

The National Institutes of Health (NIH) launched the Rapid Acceleration of Diagnostics (RADx<sup>SM</sup>) 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 object...

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Bibliographic Details
Main Authors: Laura Gibson, Nisha Fahey, Nathaniel Hafer, Bryan Buchholz, Denise Dunlap, Robert Murphy, Chad Achenbach, Cheryl Stone, Rebecca Cleeton, Jared O'Neal, Jennifer Frediani, Miriam Vos, Oliver Brand, Risha Nayee, Leona Wells, Wilbur Lam, Greg Martin, Yukari Manabe, Matthew Robinson, John Broach, Jeffrey Olgin, Bruce Barton, Stephenie Lemon, Allison Blodgett, David McManus
Format: Article
Language:English
Published: IEEE 2021-01-01
Series:IEEE Open Journal of Engineering in Medicine and Biology
Subjects:
SARS-CoV-2
COVID-19
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point-of-care testing
rapid acceleration of diagnostics
Online Access:https://ieeexplore.ieee.org/document/9418528/
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Summary:The National Institutes of Health (NIH) launched the Rapid Acceleration of Diagnostics (RADx<sup>SM</sup>) 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.
ISSN:2644-1276

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