Cargando…

The European clinical research response to optimise treatment of patients with COVID-19: lessons learned, future perspective, and recommendations

Clinicians have worked feverishly to treat patients with COVID-19 while also carrying out clinical research studies. We discuss how the clinical research community responded to the pandemic in Europe, what lessons were learned, and provide recommendations for future clinical research response during...

Descripción completa

Detalles Bibliográficos
Autores principales: Goossens, Herman, Derde, Lennie, Horby, Peter, Bonten, Marc
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier Ltd. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8691848/
https://www.ncbi.nlm.nih.gov/pubmed/34951954
http://dx.doi.org/10.1016/S1473-3099(21)00705-2
_version_ 1784618833771757568
author Goossens, Herman
Derde, Lennie
Horby, Peter
Bonten, Marc
author_facet Goossens, Herman
Derde, Lennie
Horby, Peter
Bonten, Marc
author_sort Goossens, Herman
collection PubMed
description Clinicians have worked feverishly to treat patients with COVID-19 while also carrying out clinical research studies. We discuss how the clinical research community responded to the pandemic in Europe, what lessons were learned, and provide recommendations for future clinical research response during pandemics. We focused on two platform trials: RECOVERY and REMAP-CAP. Both trials were able to enrol patients very rapidly during the beginning of the pandemic because of pre-established structures and procedures, and because they share simple execution and flexibility to adjust when evidence emergences. However, contracting, regulatory hurdles, and competition with (often inadequately designed or underpowered) national trials was a major challenge in several EU countries. We recommend the creation of structures and partnerships that facilitate prioritisation of clinical research, simplification of clinical trial delivery, development of digital models and procedures for data collection and sharing, development of a mechanism to rapidly leverage pandemic funding and to connect EU funding with national funding, and investment in clinical trial networks, platform trials, and master protocols. Finally, the future pandemic clinical research response of the EU should be embedded in the global response. We believe that globally connected clinical trial networks will be essential to respond more effectively to future infectious diseases outbreaks.
format Online
Article
Text
id pubmed-8691848
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher Elsevier Ltd.
record_format MEDLINE/PubMed
spelling pubmed-86918482021-12-22 The European clinical research response to optimise treatment of patients with COVID-19: lessons learned, future perspective, and recommendations Goossens, Herman Derde, Lennie Horby, Peter Bonten, Marc Lancet Infect Dis Personal View Clinicians have worked feverishly to treat patients with COVID-19 while also carrying out clinical research studies. We discuss how the clinical research community responded to the pandemic in Europe, what lessons were learned, and provide recommendations for future clinical research response during pandemics. We focused on two platform trials: RECOVERY and REMAP-CAP. Both trials were able to enrol patients very rapidly during the beginning of the pandemic because of pre-established structures and procedures, and because they share simple execution and flexibility to adjust when evidence emergences. However, contracting, regulatory hurdles, and competition with (often inadequately designed or underpowered) national trials was a major challenge in several EU countries. We recommend the creation of structures and partnerships that facilitate prioritisation of clinical research, simplification of clinical trial delivery, development of digital models and procedures for data collection and sharing, development of a mechanism to rapidly leverage pandemic funding and to connect EU funding with national funding, and investment in clinical trial networks, platform trials, and master protocols. Finally, the future pandemic clinical research response of the EU should be embedded in the global response. We believe that globally connected clinical trial networks will be essential to respond more effectively to future infectious diseases outbreaks. Elsevier Ltd. 2022-05 2021-12-21 /pmc/articles/PMC8691848/ /pubmed/34951954 http://dx.doi.org/10.1016/S1473-3099(21)00705-2 Text en © 2021 Elsevier Ltd. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Personal View
Goossens, Herman
Derde, Lennie
Horby, Peter
Bonten, Marc
The European clinical research response to optimise treatment of patients with COVID-19: lessons learned, future perspective, and recommendations
title The European clinical research response to optimise treatment of patients with COVID-19: lessons learned, future perspective, and recommendations
title_full The European clinical research response to optimise treatment of patients with COVID-19: lessons learned, future perspective, and recommendations
title_fullStr The European clinical research response to optimise treatment of patients with COVID-19: lessons learned, future perspective, and recommendations
title_full_unstemmed The European clinical research response to optimise treatment of patients with COVID-19: lessons learned, future perspective, and recommendations
title_short The European clinical research response to optimise treatment of patients with COVID-19: lessons learned, future perspective, and recommendations
title_sort european clinical research response to optimise treatment of patients with covid-19: lessons learned, future perspective, and recommendations
topic Personal View
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8691848/
https://www.ncbi.nlm.nih.gov/pubmed/34951954
http://dx.doi.org/10.1016/S1473-3099(21)00705-2
work_keys_str_mv AT goossensherman theeuropeanclinicalresearchresponsetooptimisetreatmentofpatientswithcovid19lessonslearnedfutureperspectiveandrecommendations
AT derdelennie theeuropeanclinicalresearchresponsetooptimisetreatmentofpatientswithcovid19lessonslearnedfutureperspectiveandrecommendations
AT horbypeter theeuropeanclinicalresearchresponsetooptimisetreatmentofpatientswithcovid19lessonslearnedfutureperspectiveandrecommendations
AT bontenmarc theeuropeanclinicalresearchresponsetooptimisetreatmentofpatientswithcovid19lessonslearnedfutureperspectiveandrecommendations
AT goossensherman europeanclinicalresearchresponsetooptimisetreatmentofpatientswithcovid19lessonslearnedfutureperspectiveandrecommendations
AT derdelennie europeanclinicalresearchresponsetooptimisetreatmentofpatientswithcovid19lessonslearnedfutureperspectiveandrecommendations
AT horbypeter europeanclinicalresearchresponsetooptimisetreatmentofpatientswithcovid19lessonslearnedfutureperspectiveandrecommendations
AT bontenmarc europeanclinicalresearchresponsetooptimisetreatmentofpatientswithcovid19lessonslearnedfutureperspectiveandrecommendations