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

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 BroachJeffrey Olgin, Bruce Barton, Stephenie Lemon, Allison Blodgett, David McManus

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

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.

Original languageEnglish (US)
Article number9418528
Pages (from-to)152-157
Number of pages6
JournalIEEE Open Journal of Engineering in Medicine and Biology
Volume2
DOIs
StatePublished - 2021

Keywords

  • COVID-19
  • SARS-CoV-2
  • in vitro diagnostics
  • point-of-care testing
  • rapid acceleration of diagnostics

ASJC Scopus subject areas

  • Biomedical Engineering

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