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. 2021 Apr 28:2:152-157.
doi: 10.1109/OJEMB.2021.3070830. eCollection 2021.

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

Laura Gibson  1 , Nisha Fahey  1 , Nathaniel Hafer  1 , Bryan Buchholz  2 , Denise Dunlap  2 , Robert Murphy  3 , Chad Achenbach  3 , Cheryl Stone  4 , Rebecca Cleeton  4 , Jared O'Neal  5 , Jennifer Frediani  6 , Miriam Vos  5 , Oliver Brand  7 , Risha Nayee  5 , Leona Wells  5 , Wilbur Lam  5 , Greg Martin  5 , Yukari Manabe  8 , Matthew Robinson  8 , John Broach  1 , Jeffrey Olgin  9 , Bruce Barton  1 , Stephenie Lemon  1 , Allison Blodgett  1 , David McManus  1
Affiliations

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

Laura Gibson et al. IEEE Open J Eng Med Biol. .

Abstract

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.

Keywords: COVID-19; SARS-CoV-2; [Formula: see text] diagnostics; point-of-care testing; rapid acceleration of diagnostics.

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Figures

Fig. 1.
Fig. 1.
Clinical studies core organizational structure.
Fig. 2.
Fig. 2.
Clinical studies core project workflow.
See this image and copyright information in PMC

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