Cargando…

The importance of appropriate selection of clinical endpoints in outpatient COVID-19 clinical trials

Clinical trial endpoints must be carefully and intentionally selected so that the results of the trial can be used to inform policy- and decision-making. The relative importance of potential endpoints often depends on the stakeholder, with patients having different preferences to policymakers and re...

Descripción completa

Detalles Bibliográficos
Autores principales: Thorlund, Kristian, Smith, Davey, Linsell, Christopher, White, Nicholas, Butler, Christopher, Boulware, David, Currier, Judith, Harari, Ofir, Lhomme, Edouard, Strub-Wourgaft, Nathalie, Adam, Stacey, Mills, Edward
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10107578/
https://www.ncbi.nlm.nih.gov/pubmed/37069219
http://dx.doi.org/10.1038/s43856-023-00281-1
_version_ 1785026636505153536
author Thorlund, Kristian
Smith, Davey
Linsell, Christopher
White, Nicholas
Butler, Christopher
Boulware, David
Currier, Judith
Harari, Ofir
Lhomme, Edouard
Strub-Wourgaft, Nathalie
Adam, Stacey
Mills, Edward
author_facet Thorlund, Kristian
Smith, Davey
Linsell, Christopher
White, Nicholas
Butler, Christopher
Boulware, David
Currier, Judith
Harari, Ofir
Lhomme, Edouard
Strub-Wourgaft, Nathalie
Adam, Stacey
Mills, Edward
author_sort Thorlund, Kristian
collection PubMed
description Clinical trial endpoints must be carefully and intentionally selected so that the results of the trial can be used to inform policy- and decision-making. The relative importance of potential endpoints often depends on the stakeholder, with patients having different preferences to policymakers and regulators. The set up of clinical trials for COVID-19 was problematic, as endpoints that could be reasonably measured did not always match the efficacy endpoints usually required by guideline panels. Thus, different endpoints were used, which made the timely comparison and evaluation of interventions difficult. Here we discuss the evolution of the COVID-19 landscape and the effect this is having on the selection of consistent and measurable clinical trial endpoints. Using appropriate endpoints is crucial for researchers to offer the most reliable, valid, and interpretable results possible.
format Online
Article
Text
id pubmed-10107578
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher Nature Publishing Group UK
record_format MEDLINE/PubMed
spelling pubmed-101075782023-04-18 The importance of appropriate selection of clinical endpoints in outpatient COVID-19 clinical trials Thorlund, Kristian Smith, Davey Linsell, Christopher White, Nicholas Butler, Christopher Boulware, David Currier, Judith Harari, Ofir Lhomme, Edouard Strub-Wourgaft, Nathalie Adam, Stacey Mills, Edward Commun Med (Lond) Perspective Clinical trial endpoints must be carefully and intentionally selected so that the results of the trial can be used to inform policy- and decision-making. The relative importance of potential endpoints often depends on the stakeholder, with patients having different preferences to policymakers and regulators. The set up of clinical trials for COVID-19 was problematic, as endpoints that could be reasonably measured did not always match the efficacy endpoints usually required by guideline panels. Thus, different endpoints were used, which made the timely comparison and evaluation of interventions difficult. Here we discuss the evolution of the COVID-19 landscape and the effect this is having on the selection of consistent and measurable clinical trial endpoints. Using appropriate endpoints is crucial for researchers to offer the most reliable, valid, and interpretable results possible. Nature Publishing Group UK 2023-04-17 /pmc/articles/PMC10107578/ /pubmed/37069219 http://dx.doi.org/10.1038/s43856-023-00281-1 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This 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 license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license 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 license, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Perspective
Thorlund, Kristian
Smith, Davey
Linsell, Christopher
White, Nicholas
Butler, Christopher
Boulware, David
Currier, Judith
Harari, Ofir
Lhomme, Edouard
Strub-Wourgaft, Nathalie
Adam, Stacey
Mills, Edward
The importance of appropriate selection of clinical endpoints in outpatient COVID-19 clinical trials
title The importance of appropriate selection of clinical endpoints in outpatient COVID-19 clinical trials
title_full The importance of appropriate selection of clinical endpoints in outpatient COVID-19 clinical trials
title_fullStr The importance of appropriate selection of clinical endpoints in outpatient COVID-19 clinical trials
title_full_unstemmed The importance of appropriate selection of clinical endpoints in outpatient COVID-19 clinical trials
title_short The importance of appropriate selection of clinical endpoints in outpatient COVID-19 clinical trials
title_sort importance of appropriate selection of clinical endpoints in outpatient covid-19 clinical trials
topic Perspective
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10107578/
https://www.ncbi.nlm.nih.gov/pubmed/37069219
http://dx.doi.org/10.1038/s43856-023-00281-1
work_keys_str_mv AT thorlundkristian theimportanceofappropriateselectionofclinicalendpointsinoutpatientcovid19clinicaltrials
AT smithdavey theimportanceofappropriateselectionofclinicalendpointsinoutpatientcovid19clinicaltrials
AT linsellchristopher theimportanceofappropriateselectionofclinicalendpointsinoutpatientcovid19clinicaltrials
AT whitenicholas theimportanceofappropriateselectionofclinicalendpointsinoutpatientcovid19clinicaltrials
AT butlerchristopher theimportanceofappropriateselectionofclinicalendpointsinoutpatientcovid19clinicaltrials
AT boulwaredavid theimportanceofappropriateselectionofclinicalendpointsinoutpatientcovid19clinicaltrials
AT currierjudith theimportanceofappropriateselectionofclinicalendpointsinoutpatientcovid19clinicaltrials
AT harariofir theimportanceofappropriateselectionofclinicalendpointsinoutpatientcovid19clinicaltrials
AT lhommeedouard theimportanceofappropriateselectionofclinicalendpointsinoutpatientcovid19clinicaltrials
AT strubwourgaftnathalie theimportanceofappropriateselectionofclinicalendpointsinoutpatientcovid19clinicaltrials
AT adamstacey theimportanceofappropriateselectionofclinicalendpointsinoutpatientcovid19clinicaltrials
AT millsedward theimportanceofappropriateselectionofclinicalendpointsinoutpatientcovid19clinicaltrials
AT thorlundkristian importanceofappropriateselectionofclinicalendpointsinoutpatientcovid19clinicaltrials
AT smithdavey importanceofappropriateselectionofclinicalendpointsinoutpatientcovid19clinicaltrials
AT linsellchristopher importanceofappropriateselectionofclinicalendpointsinoutpatientcovid19clinicaltrials
AT whitenicholas importanceofappropriateselectionofclinicalendpointsinoutpatientcovid19clinicaltrials
AT butlerchristopher importanceofappropriateselectionofclinicalendpointsinoutpatientcovid19clinicaltrials
AT boulwaredavid importanceofappropriateselectionofclinicalendpointsinoutpatientcovid19clinicaltrials
AT currierjudith importanceofappropriateselectionofclinicalendpointsinoutpatientcovid19clinicaltrials
AT harariofir importanceofappropriateselectionofclinicalendpointsinoutpatientcovid19clinicaltrials
AT lhommeedouard importanceofappropriateselectionofclinicalendpointsinoutpatientcovid19clinicaltrials
AT strubwourgaftnathalie importanceofappropriateselectionofclinicalendpointsinoutpatientcovid19clinicaltrials
AT adamstacey importanceofappropriateselectionofclinicalendpointsinoutpatientcovid19clinicaltrials
AT millsedward importanceofappropriateselectionofclinicalendpointsinoutpatientcovid19clinicaltrials