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Challenges of conducting clinical trials during the SARS-CoV-2 pandemic : the ASCEND global program experience
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Johansen, Kirsten L., Acharya, Anjali, Cizman, Borut, Cobitz, Alexander R., Correa-Rotter, Ricardo, Dasgupta, Indranil, Kher, Vijay, Lopes, Renato D., Matsumoto, Leonardo, Meadowcroft, Amy M., Merege Vieira Neto, Osvaldo, Okabe, Marilu, Rayner, Brian, Silva, Arnold, Thomas, Hilary and Singh, Ajay K. (2022) Challenges of conducting clinical trials during the SARS-CoV-2 pandemic : the ASCEND global program experience. Kidney360, 3 (4). pp. 728-733. doi:10.34067/KID.0006212021 ISSN 2641-7650.
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Official URL: https://doi.org/10.34067/KID.0006212021
Abstract
The coronavirus disease 2019 (COVID-19) pandemic has had an unprecedented effect on health and health care. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has strained health care systems and caused disruption to non-COVID-19-related health care. Although the premature interruption or disruption of clinical trials is less well recognized, it has the potential to threaten the development of new non-COVID-19-related therapies (1⇓–3).
Study disruptions need to be rapidly identified and addressed to preserve the integrity of ongoing studies and the design of new ones. Here, we describe the challenges that arose in three global phase 3 trials and the strategies undertaken to maintain and adapt the conduct of the studies safely during the COVID-19 pandemic.
Item Type: | Journal Article | ||||||
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Subjects: | R Medicine > R Medicine (General) | ||||||
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School | ||||||
Library of Congress Subject Headings (LCSH): | Clinical trials, COVID-19 Pandemic, 2020- | ||||||
Journal or Publication Title: | Kidney360 | ||||||
Publisher: | ASN | ||||||
ISSN: | 2641-7650 | ||||||
Official Date: | 28 April 2022 | ||||||
Dates: |
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Volume: | 3 | ||||||
Number: | 4 | ||||||
Page Range: | pp. 728-733 | ||||||
DOI: | 10.34067/KID.0006212021 | ||||||
Status: | Peer Reviewed | ||||||
Publication Status: | Published | ||||||
Access rights to Published version: | Restricted or Subscription Access | ||||||
Copyright Holders: | Copyright © 2022 by the American Society of Nephrology | ||||||
Date of first compliant deposit: | 29 June 2022 | ||||||
Date of first compliant Open Access: | 29 June 2022 | ||||||
RIOXX Funder/Project Grant: |
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