IEEE Open Journal of Engineering in Medicine and Biology (Jan 2021)

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 Broach,
  • Jeffrey Olgin,
  • Bruce Barton,
  • Stephenie Lemon,
  • Allison Blodgett,
  • David McManus

DOI
https://doi.org/10.1109/OJEMB.2021.3070830
Journal volume & issue
Vol. 2
pp. 152 – 157

Abstract

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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.

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