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Guidance on the Conduct of Clinical Research within OECD Countries during the Early Stages of the COVID-19 Pandemic: A Systematic Review

Background: In response to the COVID-19 pandemic, member countries of the Organisation for Economic Co-operation and Development (OECD) rapidly published guidance regarding the conduct of clinical research. A systematic review was conducted to explore the recommendations issued in relation to the co...

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Autores principales: Bhutkar, Renu, Collins, Jack C., O’Reilly, Claire L., El-Den, Sarira
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9844363/
https://www.ncbi.nlm.nih.gov/pubmed/36649025
http://dx.doi.org/10.3390/pharmacy11010015
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author Bhutkar, Renu
Collins, Jack C.
O’Reilly, Claire L.
El-Den, Sarira
author_facet Bhutkar, Renu
Collins, Jack C.
O’Reilly, Claire L.
El-Den, Sarira
author_sort Bhutkar, Renu
collection PubMed
description Background: In response to the COVID-19 pandemic, member countries of the Organisation for Economic Co-operation and Development (OECD) rapidly published guidance regarding the conduct of clinical research. A systematic review was conducted to explore the recommendations issued in relation to the commencement, continuation and termination of clinical research during the early phases of the pandemic. Methods: Searches consisting of the terms “COVID-19”, “clinical research”, and “guidance”, were conducted in PubMed, Embase, MEDLINE, Trip, Guidelines International Network, and Google in April–May 2021 (up to 4 May 2021). Data were extracted from guidance published from OECD member countries and mapped to inductively-developed categories. Results: 9419 references were systematically screened, resulting in the inclusion of 46 publications from 27 OECD countries. Thirty-three sources made recommendations regarding monitoring, risk-benefit assessments and information technology. There was limited specific recommendations made in relation to personal protective equipment (PPE) in the included guidance. Findings demonstrate that guidance differed by publication date demonstrating the rapidly evolving environment within which research was conducted. Importantly, many organisations opted to endorse existing guidance published by the United States’ Food and Drug Administration and the European Medicines Agency rather than develop their own recommendations. Conclusions: Given the rapidly evolving nature of the pandemic, particularly in the early stages, findings demonstrate the global response in relation to clinical research conduct, thereby providing important insights for future public health emergencies.
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spelling pubmed-98443632023-01-18 Guidance on the Conduct of Clinical Research within OECD Countries during the Early Stages of the COVID-19 Pandemic: A Systematic Review Bhutkar, Renu Collins, Jack C. O’Reilly, Claire L. El-Den, Sarira Pharmacy (Basel) Systematic Review Background: In response to the COVID-19 pandemic, member countries of the Organisation for Economic Co-operation and Development (OECD) rapidly published guidance regarding the conduct of clinical research. A systematic review was conducted to explore the recommendations issued in relation to the commencement, continuation and termination of clinical research during the early phases of the pandemic. Methods: Searches consisting of the terms “COVID-19”, “clinical research”, and “guidance”, were conducted in PubMed, Embase, MEDLINE, Trip, Guidelines International Network, and Google in April–May 2021 (up to 4 May 2021). Data were extracted from guidance published from OECD member countries and mapped to inductively-developed categories. Results: 9419 references were systematically screened, resulting in the inclusion of 46 publications from 27 OECD countries. Thirty-three sources made recommendations regarding monitoring, risk-benefit assessments and information technology. There was limited specific recommendations made in relation to personal protective equipment (PPE) in the included guidance. Findings demonstrate that guidance differed by publication date demonstrating the rapidly evolving environment within which research was conducted. Importantly, many organisations opted to endorse existing guidance published by the United States’ Food and Drug Administration and the European Medicines Agency rather than develop their own recommendations. Conclusions: Given the rapidly evolving nature of the pandemic, particularly in the early stages, findings demonstrate the global response in relation to clinical research conduct, thereby providing important insights for future public health emergencies. MDPI 2023-01-12 /pmc/articles/PMC9844363/ /pubmed/36649025 http://dx.doi.org/10.3390/pharmacy11010015 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Systematic Review
Bhutkar, Renu
Collins, Jack C.
O’Reilly, Claire L.
El-Den, Sarira
Guidance on the Conduct of Clinical Research within OECD Countries during the Early Stages of the COVID-19 Pandemic: A Systematic Review
title Guidance on the Conduct of Clinical Research within OECD Countries during the Early Stages of the COVID-19 Pandemic: A Systematic Review
title_full Guidance on the Conduct of Clinical Research within OECD Countries during the Early Stages of the COVID-19 Pandemic: A Systematic Review
title_fullStr Guidance on the Conduct of Clinical Research within OECD Countries during the Early Stages of the COVID-19 Pandemic: A Systematic Review
title_full_unstemmed Guidance on the Conduct of Clinical Research within OECD Countries during the Early Stages of the COVID-19 Pandemic: A Systematic Review
title_short Guidance on the Conduct of Clinical Research within OECD Countries during the Early Stages of the COVID-19 Pandemic: A Systematic Review
title_sort guidance on the conduct of clinical research within oecd countries during the early stages of the covid-19 pandemic: a systematic review
topic Systematic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9844363/
https://www.ncbi.nlm.nih.gov/pubmed/36649025
http://dx.doi.org/10.3390/pharmacy11010015
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