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How COVID-19 changed clinical research strategies: a global survey

OBJECTIVE: Clinical research has faced new challenges during the COVID-19 pandemic, leading to excessive operational demands affecting all stakeholders. We evaluated the impact of COVID-19 on clinical research strategies and compared different adaptations by regulatory bodies and academic research i...

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Autores principales: Bauer, Annina, Eskat, Anja, Ntekim, Atara, Wong, Creany, Eberle, Deborah, Hedayati, Elham, Tay, Fabian, Yau, Henry, Stockley, Louise, de Medina Redondo, María, Şen, Selçuk, Egert-Schwender, Silvia, Üresin, Yağız, Grossmann, Regina
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9087250/
https://www.ncbi.nlm.nih.gov/pubmed/35469473
http://dx.doi.org/10.1177/03000605221093179
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author Bauer, Annina
Eskat, Anja
Ntekim, Atara
Wong, Creany
Eberle, Deborah
Hedayati, Elham
Tay, Fabian
Yau, Henry
Stockley, Louise
de Medina Redondo, María
Şen, Selçuk
Egert-Schwender, Silvia
Üresin, Yağız
Grossmann, Regina
author_facet Bauer, Annina
Eskat, Anja
Ntekim, Atara
Wong, Creany
Eberle, Deborah
Hedayati, Elham
Tay, Fabian
Yau, Henry
Stockley, Louise
de Medina Redondo, María
Şen, Selçuk
Egert-Schwender, Silvia
Üresin, Yağız
Grossmann, Regina
author_sort Bauer, Annina
collection PubMed
description OBJECTIVE: Clinical research has faced new challenges during the COVID-19 pandemic, leading to excessive operational demands affecting all stakeholders. We evaluated the impact of COVID-19 on clinical research strategies and compared different adaptations by regulatory bodies and academic research institutions in a global context, exploring what can be learned for possible future pandemics. METHODS: We conducted a cross-sectional online survey and identified and assessed different COVID-19-specific adaptation strategies used by academic research institutions and regulatory bodies. RESULTS: All 19 participating academic research institutions developed and followed similar strategies, including preventive measures, manpower recruitment, and prioritisation of COVID-19 projects. In contrast, measures for centralised management or coordination of COVID-19 projects, project preselection, and funding were handled differently amongst institutions. Regulatory bodies responded similarly to the pandemic by implementing fast-track authorisation procedures for COVID-19 projects and developing guidance documents. Quality and consistency of the information and advice provided was rated differently amongst institutions. CONCLUSION: Both academic research institutions and regulatory bodies worldwide were able to cope with challenges during the COVID-19 pandemic by developing similar strategies. We identified some unique approaches to ensure fast and efficient responses to a pandemic. Ethical concerns should be addressed in any new decision-making process.
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spelling pubmed-90872502022-05-11 How COVID-19 changed clinical research strategies: a global survey Bauer, Annina Eskat, Anja Ntekim, Atara Wong, Creany Eberle, Deborah Hedayati, Elham Tay, Fabian Yau, Henry Stockley, Louise de Medina Redondo, María Şen, Selçuk Egert-Schwender, Silvia Üresin, Yağız Grossmann, Regina J Int Med Res Prospective Clinical Research Report OBJECTIVE: Clinical research has faced new challenges during the COVID-19 pandemic, leading to excessive operational demands affecting all stakeholders. We evaluated the impact of COVID-19 on clinical research strategies and compared different adaptations by regulatory bodies and academic research institutions in a global context, exploring what can be learned for possible future pandemics. METHODS: We conducted a cross-sectional online survey and identified and assessed different COVID-19-specific adaptation strategies used by academic research institutions and regulatory bodies. RESULTS: All 19 participating academic research institutions developed and followed similar strategies, including preventive measures, manpower recruitment, and prioritisation of COVID-19 projects. In contrast, measures for centralised management or coordination of COVID-19 projects, project preselection, and funding were handled differently amongst institutions. Regulatory bodies responded similarly to the pandemic by implementing fast-track authorisation procedures for COVID-19 projects and developing guidance documents. Quality and consistency of the information and advice provided was rated differently amongst institutions. CONCLUSION: Both academic research institutions and regulatory bodies worldwide were able to cope with challenges during the COVID-19 pandemic by developing similar strategies. We identified some unique approaches to ensure fast and efficient responses to a pandemic. Ethical concerns should be addressed in any new decision-making process. SAGE Publications 2022-04-25 /pmc/articles/PMC9087250/ /pubmed/35469473 http://dx.doi.org/10.1177/03000605221093179 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by-nc/4.0/Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Prospective Clinical Research Report
Bauer, Annina
Eskat, Anja
Ntekim, Atara
Wong, Creany
Eberle, Deborah
Hedayati, Elham
Tay, Fabian
Yau, Henry
Stockley, Louise
de Medina Redondo, María
Şen, Selçuk
Egert-Schwender, Silvia
Üresin, Yağız
Grossmann, Regina
How COVID-19 changed clinical research strategies: a global survey
title How COVID-19 changed clinical research strategies: a global survey
title_full How COVID-19 changed clinical research strategies: a global survey
title_fullStr How COVID-19 changed clinical research strategies: a global survey
title_full_unstemmed How COVID-19 changed clinical research strategies: a global survey
title_short How COVID-19 changed clinical research strategies: a global survey
title_sort how covid-19 changed clinical research strategies: a global survey
topic Prospective Clinical Research Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9087250/
https://www.ncbi.nlm.nih.gov/pubmed/35469473
http://dx.doi.org/10.1177/03000605221093179
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