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Clinical Trials for COVID‐19: Can we Better Use the Short Window of Opportunity?

The scientific community has risen to the coronavirus disease 2019 (COVID‐19) challenge, coming up with an impressive list of candidate drugs and vaccines targeting an array of pharmacological and immunological mechanisms. Yet, generating clinical evidence of efficacy and safety of these candidate t...

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Autores principales: Eichler, Hans‐Georg, Cavaleri, Marco, Enzmann, Harald, Scotti, Francesca, Sepodes, Bruno, Sweeney, Fergus, Vamvakas, Spiros, Rasi, Guido
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7272975/
https://www.ncbi.nlm.nih.gov/pubmed/32407539
http://dx.doi.org/10.1002/cpt.1891
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author Eichler, Hans‐Georg
Cavaleri, Marco
Enzmann, Harald
Scotti, Francesca
Sepodes, Bruno
Sweeney, Fergus
Vamvakas, Spiros
Rasi, Guido
author_facet Eichler, Hans‐Georg
Cavaleri, Marco
Enzmann, Harald
Scotti, Francesca
Sepodes, Bruno
Sweeney, Fergus
Vamvakas, Spiros
Rasi, Guido
author_sort Eichler, Hans‐Georg
collection PubMed
description The scientific community has risen to the coronavirus disease 2019 (COVID‐19) challenge, coming up with an impressive list of candidate drugs and vaccines targeting an array of pharmacological and immunological mechanisms. Yet, generating clinical evidence of efficacy and safety of these candidate treatments may be frustrated by the absence of comprehensive trial coordination mechanisms. Many small stand‐alone trials and observational studies of single‐agent interventions are currently running or in planning; many of these will likely not deliver robust results that could support regulatory and patient‐level treatment decisions. In this paper, we discuss actions that all stakeholders in the clinical trial ecosystem need to take to ensure that the window of opportunity during this pandemic will not shut, both for patients in need of treatment and for researchers to conduct decision‐relevant clinical trials.
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spelling pubmed-72729752020-06-05 Clinical Trials for COVID‐19: Can we Better Use the Short Window of Opportunity? Eichler, Hans‐Georg Cavaleri, Marco Enzmann, Harald Scotti, Francesca Sepodes, Bruno Sweeney, Fergus Vamvakas, Spiros Rasi, Guido Clin Pharmacol Ther Reviews The scientific community has risen to the coronavirus disease 2019 (COVID‐19) challenge, coming up with an impressive list of candidate drugs and vaccines targeting an array of pharmacological and immunological mechanisms. Yet, generating clinical evidence of efficacy and safety of these candidate treatments may be frustrated by the absence of comprehensive trial coordination mechanisms. Many small stand‐alone trials and observational studies of single‐agent interventions are currently running or in planning; many of these will likely not deliver robust results that could support regulatory and patient‐level treatment decisions. In this paper, we discuss actions that all stakeholders in the clinical trial ecosystem need to take to ensure that the window of opportunity during this pandemic will not shut, both for patients in need of treatment and for researchers to conduct decision‐relevant clinical trials. John Wiley and Sons Inc. 2020-06-12 2020-10 /pmc/articles/PMC7272975/ /pubmed/32407539 http://dx.doi.org/10.1002/cpt.1891 Text en © 2020 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Reviews
Eichler, Hans‐Georg
Cavaleri, Marco
Enzmann, Harald
Scotti, Francesca
Sepodes, Bruno
Sweeney, Fergus
Vamvakas, Spiros
Rasi, Guido
Clinical Trials for COVID‐19: Can we Better Use the Short Window of Opportunity?
title Clinical Trials for COVID‐19: Can we Better Use the Short Window of Opportunity?
title_full Clinical Trials for COVID‐19: Can we Better Use the Short Window of Opportunity?
title_fullStr Clinical Trials for COVID‐19: Can we Better Use the Short Window of Opportunity?
title_full_unstemmed Clinical Trials for COVID‐19: Can we Better Use the Short Window of Opportunity?
title_short Clinical Trials for COVID‐19: Can we Better Use the Short Window of Opportunity?
title_sort clinical trials for covid‐19: can we better use the short window of opportunity?
topic Reviews
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7272975/
https://www.ncbi.nlm.nih.gov/pubmed/32407539
http://dx.doi.org/10.1002/cpt.1891
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