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Managing clinical trials during COVID-19: experience from a clinical research facility

There is a dearth of literature on best practices for managing clinical trials, and little is understood on the role of the clinical trial manager. The COVID-19 pandemic has brought this into focus, and the continuance of clinical trials worldwide has been catapulted into a state of uncertainty as c...

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Autores principales: Shiely, Frances, Foley, Jean, Stone, Amy, Cobbe, Emma, Browne, Shaunagh, Murphy, Ellen, Kelsey, Maeve, Walsh-Crowley, Joanne, Eustace, Joseph A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7812560/
https://www.ncbi.nlm.nih.gov/pubmed/33461595
http://dx.doi.org/10.1186/s13063-020-05004-8
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author Shiely, Frances
Foley, Jean
Stone, Amy
Cobbe, Emma
Browne, Shaunagh
Murphy, Ellen
Kelsey, Maeve
Walsh-Crowley, Joanne
Eustace, Joseph A.
author_facet Shiely, Frances
Foley, Jean
Stone, Amy
Cobbe, Emma
Browne, Shaunagh
Murphy, Ellen
Kelsey, Maeve
Walsh-Crowley, Joanne
Eustace, Joseph A.
author_sort Shiely, Frances
collection PubMed
description There is a dearth of literature on best practices for managing clinical trials, and little is understood on the role of the clinical trial manager. The COVID-19 pandemic has brought this into focus, and the continuance of clinical trials worldwide has been catapulted into a state of uncertainty as countries enter lockdown to manage the spread of the virus. Participant retention is an ongoing issue in clinical trials, and the concern is that in the current pandemic environment, attrition will be an issue which could potentially jeopardise trial completion. The current situation has necessitated timely problem solving by the trial manager to ensure trials remain open, and most importantly, that participant safety, paramount in clinical trials, is monitored. The purpose of our study is to highlight key issues arising in the management of clinical trials during a pandemic from first-hand experience in a clinical research facility managing both academic and commercial clinical trials. We offer some practical guidance on solution implementation.
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spelling pubmed-78125602021-01-18 Managing clinical trials during COVID-19: experience from a clinical research facility Shiely, Frances Foley, Jean Stone, Amy Cobbe, Emma Browne, Shaunagh Murphy, Ellen Kelsey, Maeve Walsh-Crowley, Joanne Eustace, Joseph A. Trials Commentary There is a dearth of literature on best practices for managing clinical trials, and little is understood on the role of the clinical trial manager. The COVID-19 pandemic has brought this into focus, and the continuance of clinical trials worldwide has been catapulted into a state of uncertainty as countries enter lockdown to manage the spread of the virus. Participant retention is an ongoing issue in clinical trials, and the concern is that in the current pandemic environment, attrition will be an issue which could potentially jeopardise trial completion. The current situation has necessitated timely problem solving by the trial manager to ensure trials remain open, and most importantly, that participant safety, paramount in clinical trials, is monitored. The purpose of our study is to highlight key issues arising in the management of clinical trials during a pandemic from first-hand experience in a clinical research facility managing both academic and commercial clinical trials. We offer some practical guidance on solution implementation. BioMed Central 2021-01-18 /pmc/articles/PMC7812560/ /pubmed/33461595 http://dx.doi.org/10.1186/s13063-020-05004-8 Text en © The Author(s) 2021 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Commentary
Shiely, Frances
Foley, Jean
Stone, Amy
Cobbe, Emma
Browne, Shaunagh
Murphy, Ellen
Kelsey, Maeve
Walsh-Crowley, Joanne
Eustace, Joseph A.
Managing clinical trials during COVID-19: experience from a clinical research facility
title Managing clinical trials during COVID-19: experience from a clinical research facility
title_full Managing clinical trials during COVID-19: experience from a clinical research facility
title_fullStr Managing clinical trials during COVID-19: experience from a clinical research facility
title_full_unstemmed Managing clinical trials during COVID-19: experience from a clinical research facility
title_short Managing clinical trials during COVID-19: experience from a clinical research facility
title_sort managing clinical trials during covid-19: experience from a clinical research facility
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7812560/
https://www.ncbi.nlm.nih.gov/pubmed/33461595
http://dx.doi.org/10.1186/s13063-020-05004-8
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