TY - JOUR
T1 - The RADx Tech Clinical Studies Core
T2 - A Model for Academic Based Clinical Studies
AU - Gibson, Laura
AU - Fahey, Nisha
AU - Hafer, Nathaniel
AU - Buchholz, Bryan
AU - Dunlap, Denise
AU - Murphy, Robert
AU - Achenbach, Chad
AU - Stone, Cheryl
AU - Cleeton, Rebecca
AU - O'Neal, Jared
AU - Frediani, Jennifer
AU - Vos, Miriam
AU - Brand, Oliver
AU - Nayee, Risha
AU - Wells, Leona
AU - Lam, Wilbur
AU - Martin, Greg
AU - Manabe, Yukari
AU - Robinson, Matthew
AU - Broach, John
AU - Olgin, Jeffrey
AU - Barton, Bruce
AU - Lemon, Stephenie
AU - Blodgett, Allison
AU - McManus, David
N1 - Publisher Copyright:
© 2020 IEEE.
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - COVID-19
KW - SARS-CoV-2
KW - in vitro diagnostics
KW - point-of-care testing
KW - rapid acceleration of diagnostics
UR - http://www.scopus.com/inward/record.url?scp=85121056845&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85121056845&partnerID=8YFLogxK
U2 - 10.1109/OJEMB.2021.3070830
DO - 10.1109/OJEMB.2021.3070830
M3 - Article
C2 - 34192287
AN - SCOPUS:85121056845
SN - 2644-1276
VL - 2
SP - 152
EP - 157
JO - IEEE Open Journal of Engineering in Medicine and Biology
JF - IEEE Open Journal of Engineering in Medicine and Biology
M1 - 9418528
ER -
