UMMS Affiliation

Department of Medicine, Division of Infectious Diseases and Immunology; Department of Pediatrics; UMass Center for Clinical and Translational Science; Department of Emergency Medicine; Department of Population and Quantitative Health Sciences; Graduate School of Nursing; Department of Medicine, Division of Cardiovascular Medicine

Publication Date

2021-04-28

Document Type

Article

Disciplines

Biomedical Engineering and Bioengineering | Diagnosis | Health and Medical Administration | Infectious Disease | Translational Medical Research | Virus Diseases

Abstract

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.

Keywords

SARS-CoV-2, COVID-19, in vitro diagnostics, point-of-care testing, rapid acceleration of diagnostics, UMCCTS funding

Rights and Permissions

This work is licensed under a Creative Commons Attribution 4.0 License. For more information, see https://creativecommons.org/licenses/by/4.0/

DOI of Published Version

10.1109/OJEMB.2021.3070830

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

Journal/Book/Conference Title

IEEE Open Journal of Engineering in Medicine and Biology

Comments

Full author list omitted for brevity. For the full list of authors, see article.

PubMed ID

34192287

Creative Commons License

Creative Commons Attribution 4.0 License
This work is licensed under a Creative Commons Attribution 4.0 License.

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