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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...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
SAGE Publications
2022
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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. |
format | Online Article Text |
id | pubmed-9087250 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | SAGE Publications |
record_format | MEDLINE/PubMed |
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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