Re-engineering The Clinical Research Enterprise in Response to COVID-19: The Clinical Translational Science Award (CTSA) experience and proposed playbook for future pandemics

The 2020 COVID-19 pandemic has had a profound impact on the clinical research enterprises at the 60 Clinical and Translational Science Award (CTSA) Hubs throughout the nation. There was simultaneously a need to expand research to obtain crucial data about disease prognosis and therapy and enormous l...

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Main Authors: Barry S. Coller, John B. Buse, Robert P. Kimberly, William G. Powderly, Martin S. Zand
Format: Article
Language:English
Published: Cambridge University Press 2021-01-01
Series:Journal of Clinical and Translational Science
Subjects:
Online Access:https://www.cambridge.org/core/product/identifier/S2059866121000108/type/journal_article
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author Barry S. Coller
John B. Buse
Robert P. Kimberly
William G. Powderly
Martin S. Zand
author_facet Barry S. Coller
John B. Buse
Robert P. Kimberly
William G. Powderly
Martin S. Zand
author_sort Barry S. Coller
collection DOAJ
description The 2020 COVID-19 pandemic has had a profound impact on the clinical research enterprises at the 60 Clinical and Translational Science Award (CTSA) Hubs throughout the nation. There was simultaneously a need to expand research to obtain crucial data about disease prognosis and therapy and enormous limitations on conducting research as localities and institutions limited travel and person-to-person contact. These imperatives resulted in major changes in the way research was conducted, including expediting Institutional Review Board review, shifting to remote interactions with participants, centralizing decision-making in prioritizing research protocols, establishing biobanks, adopting novel informatics platforms, and distributing study drugs in unconventional ways. National CTSA Steering Committee meetings provided an opportunity to share best practices and develop the idea of capturing the CTSA program experiences in a series of papers. Here we bring together the recommendations from those papers in a list of specific actions that research sites can take to strengthen operations and prepare for similar future public health emergencies. Most importantly, creative innovations developed in response to the COVID-19 pandemic deserve serious consideration for adoption as new standards, thus converting the painful trauma of the pandemic into “post-traumatic growth” that makes the clinical research enterprise stronger, more resilient, and more effective.
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spelling doaj.art-0cb98c2307cb49a9b139dbf3b8f0f7c82023-03-09T12:31:02ZengCambridge University PressJournal of Clinical and Translational Science2059-86612021-01-01510.1017/cts.2021.10Re-engineering The Clinical Research Enterprise in Response to COVID-19: The Clinical Translational Science Award (CTSA) experience and proposed playbook for future pandemicsBarry S. Coller0https://orcid.org/0000-0002-9078-7155John B. Buse1Robert P. Kimberly2William G. Powderly3Martin S. Zand4https://orcid.org/0000-0002-7095-8682Allen and Frances Adler Laboratory of Vascular Biology, Rockefeller University, New York, NY, USADepartment of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USADepartment of Medicine, University of Alabama at Birmingham, Birmingham, AL, USADivision of Infectious Diseases and Institute for Public Health, Washington University in St. Louis, St. Louis, MO, USADepartment of Medicine, University of Rochester Medical Center, Department of Medicine, Nephrology, Rochester, NY, USAThe 2020 COVID-19 pandemic has had a profound impact on the clinical research enterprises at the 60 Clinical and Translational Science Award (CTSA) Hubs throughout the nation. There was simultaneously a need to expand research to obtain crucial data about disease prognosis and therapy and enormous limitations on conducting research as localities and institutions limited travel and person-to-person contact. These imperatives resulted in major changes in the way research was conducted, including expediting Institutional Review Board review, shifting to remote interactions with participants, centralizing decision-making in prioritizing research protocols, establishing biobanks, adopting novel informatics platforms, and distributing study drugs in unconventional ways. National CTSA Steering Committee meetings provided an opportunity to share best practices and develop the idea of capturing the CTSA program experiences in a series of papers. Here we bring together the recommendations from those papers in a list of specific actions that research sites can take to strengthen operations and prepare for similar future public health emergencies. Most importantly, creative innovations developed in response to the COVID-19 pandemic deserve serious consideration for adoption as new standards, thus converting the painful trauma of the pandemic into “post-traumatic growth” that makes the clinical research enterprise stronger, more resilient, and more effective.https://www.cambridge.org/core/product/identifier/S2059866121000108/type/journal_articleCOVID-19CTSAclinical researchpandemictranslational research
spellingShingle Barry S. Coller
John B. Buse
Robert P. Kimberly
William G. Powderly
Martin S. Zand
Re-engineering The Clinical Research Enterprise in Response to COVID-19: The Clinical Translational Science Award (CTSA) experience and proposed playbook for future pandemics
Journal of Clinical and Translational Science
COVID-19
CTSA
clinical research
pandemic
translational research
title Re-engineering The Clinical Research Enterprise in Response to COVID-19: The Clinical Translational Science Award (CTSA) experience and proposed playbook for future pandemics
title_full Re-engineering The Clinical Research Enterprise in Response to COVID-19: The Clinical Translational Science Award (CTSA) experience and proposed playbook for future pandemics
title_fullStr Re-engineering The Clinical Research Enterprise in Response to COVID-19: The Clinical Translational Science Award (CTSA) experience and proposed playbook for future pandemics
title_full_unstemmed Re-engineering The Clinical Research Enterprise in Response to COVID-19: The Clinical Translational Science Award (CTSA) experience and proposed playbook for future pandemics
title_short Re-engineering The Clinical Research Enterprise in Response to COVID-19: The Clinical Translational Science Award (CTSA) experience and proposed playbook for future pandemics
title_sort re engineering the clinical research enterprise in response to covid 19 the clinical translational science award ctsa experience and proposed playbook for future pandemics
topic COVID-19
CTSA
clinical research
pandemic
translational research
url https://www.cambridge.org/core/product/identifier/S2059866121000108/type/journal_article
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