The RADx Tech Clinical Studies Core: A Model for Academic Based Clinical Studies
The National Institutes of Health (NIH) launched the Rapid Acceleration of Diagnostics (RADx<sup>SM</sup>) 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 object...
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| Format: | Article |
| Language: | English |
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IEEE
2021-01-01
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| Series: | IEEE Open Journal of Engineering in Medicine and Biology |
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| Online Access: | https://ieeexplore.ieee.org/document/9418528/ |
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| author | 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 |
| author_facet | 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 |
| author_sort | Laura Gibson |
| collection | DOAJ |
| description | The National Institutes of Health (NIH) launched the Rapid Acceleration of Diagnostics (RADx<sup>SM</sup>) 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. |
| format | Article |
| id | doaj-art-a6800932b7b2481eb322eb182cf83c35 |
| institution | Kabale University |
| issn | 2644-1276 |
| language | English |
| publishDate | 2021-01-01 |
| publisher | IEEE |
| record_format | Article |
| series | IEEE Open Journal of Engineering in Medicine and Biology |
| spelling | doaj-art-a6800932b7b2481eb322eb182cf83c352025-08-20T03:33:14ZengIEEEIEEE Open Journal of Engineering in Medicine and Biology2644-12762021-01-01215215710.1109/OJEMB.2021.30708309418528The RADx Tech Clinical Studies Core: A Model for Academic Based Clinical StudiesLaura Gibson0Nisha Fahey1https://orcid.org/0000-0001-9059-1470Nathaniel Hafer2Bryan Buchholz3Denise Dunlap4Robert Murphy5Chad Achenbach6Cheryl Stone7Rebecca Cleeton8Jared O'Neal9Jennifer Frediani10Miriam Vos11Oliver Brand12https://orcid.org/0000-0001-7438-1094Risha Nayee13Leona Wells14Wilbur Lam15Greg Martin16Yukari Manabe17Matthew Robinson18https://orcid.org/0000-0003-0376-8560John Broach19Jeffrey Olgin20Bruce Barton21Stephenie Lemon22Allison Blodgett23David McManus24University of Massachusetts Medical School, Worcester, MA, USAUniversity of Massachusetts Medical School, Worcester, MA, USAUniversity of Massachusetts Medical School, Worcester, MA, USAUniversity of Massachusetts Lowell, Lowell, MA, USAUniversity of Massachusetts Lowell, Lowell, MA, USANorthwestern University Feinberg School of Medicine, Chicago, IL, USANorthwestern University Feinberg School of Medicine, Chicago, IL, USAChildren's Healthcare of Atlanta Inc, Atlanta, GA, USAChildren's Healthcare of Atlanta Inc, Atlanta, GA, USAEmory University School of Medicine, Atlanta, GA, USAEmory University Nell Hodgson Woodruff School of Nursing, Atlanta, GA, USAEmory University School of Medicine, Atlanta, GA, USAGeorgia Institute of Technology, Atlanta, GA, USAEmory University School of Medicine, Atlanta, GA, USAEmory University School of Medicine, Atlanta, GA, USAEmory University School of Medicine, Atlanta, GA, USAEmory University School of Medicine, Atlanta, GA, USAJohns Hopkins University School of Medicine, Baltimore, MD, USAJohns Hopkins University School of Medicine, Baltimore, MD, USAUniversity of Massachusetts Medical School, Worcester, MA, USAUniversity of California San Francisco, San Francisco, CA, USAUniversity of Massachusetts Medical School, Worcester, MA, USAUniversity of Massachusetts Medical School, Worcester, MA, USAUniversity of Massachusetts Medical School, Worcester, MA, USAUniversity of Massachusetts Medical School, Worcester, MA, USAThe National Institutes of Health (NIH) launched the Rapid Acceleration of Diagnostics (RADx<sup>SM</sup>) 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.https://ieeexplore.ieee.org/document/9418528/SARS-CoV-2COVID-19<named-content xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:ali="http://www.niso.org/schemas/ali/1.0/" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" content-type="math" xlink:type="simple"> <inline-formula> <tex-math notation="LaTeX">$in\ vitro$</tex-math> </inline-formula> </named-content> diagnosticspoint-of-care testingrapid acceleration of diagnostics |
| spellingShingle | 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 The RADx Tech Clinical Studies Core: A Model for Academic Based Clinical Studies IEEE Open Journal of Engineering in Medicine and Biology SARS-CoV-2 COVID-19 <named-content xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:ali="http://www.niso.org/schemas/ali/1.0/" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" content-type="math" xlink:type="simple"> <inline-formula> <tex-math notation="LaTeX">$in\ vitro$</tex-math> </inline-formula> </named-content> diagnostics point-of-care testing rapid acceleration of diagnostics |
| title | The RADx Tech Clinical Studies Core: A Model for Academic Based Clinical Studies |
| title_full | The RADx Tech Clinical Studies Core: A Model for Academic Based Clinical Studies |
| title_fullStr | The RADx Tech Clinical Studies Core: A Model for Academic Based Clinical Studies |
| title_full_unstemmed | The RADx Tech Clinical Studies Core: A Model for Academic Based Clinical Studies |
| title_short | The RADx Tech Clinical Studies Core: A Model for Academic Based Clinical Studies |
| title_sort | radx tech clinical studies core a model for academic based clinical studies |
| topic | SARS-CoV-2 COVID-19 <named-content xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:ali="http://www.niso.org/schemas/ali/1.0/" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" content-type="math" xlink:type="simple"> <inline-formula> <tex-math notation="LaTeX">$in\ vitro$</tex-math> </inline-formula> </named-content> diagnostics point-of-care testing rapid acceleration of diagnostics |
| url | https://ieeexplore.ieee.org/document/9418528/ |
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