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Design aspects of COVID‐19 treatment trials: Improving probability and time of favorable events

As a reaction to the pandemic of the severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2), a multitude of clinical trials for the treatment of SARS‐CoV‐2 or the resulting corona disease 2019 (COVID‐19) are globally at various stages from planning to completion. Although some attempts were ma...

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Detalles Bibliográficos
Autores principales: Beyersmann, Jan, Friede, Tim, Schmoor, Claudia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8653377/
https://www.ncbi.nlm.nih.gov/pubmed/34677829
http://dx.doi.org/10.1002/bimj.202000359
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author Beyersmann, Jan
Friede, Tim
Schmoor, Claudia
author_facet Beyersmann, Jan
Friede, Tim
Schmoor, Claudia
author_sort Beyersmann, Jan
collection PubMed
description As a reaction to the pandemic of the severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2), a multitude of clinical trials for the treatment of SARS‐CoV‐2 or the resulting corona disease 2019 (COVID‐19) are globally at various stages from planning to completion. Although some attempts were made to standardize study designs, this was hindered by the ferocity of the pandemic and the need to set up clinical trials quickly. We take the view that a successful treatment of COVID‐19 patients (i) increases the probability of a recovery or improvement within a certain time interval, say 28 days; (ii) aims to expedite favorable events within this time frame; and (iii) does not increase mortality over this time period. On this background, we discuss the choice of endpoint and its analysis. Furthermore, we consider consequences of this choice for other design aspects including sample size and power and provide some guidance on the application of adaptive designs in this particular context.
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spelling pubmed-86533772021-12-08 Design aspects of COVID‐19 treatment trials: Improving probability and time of favorable events Beyersmann, Jan Friede, Tim Schmoor, Claudia Biom J Trial Design and Methodology As a reaction to the pandemic of the severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2), a multitude of clinical trials for the treatment of SARS‐CoV‐2 or the resulting corona disease 2019 (COVID‐19) are globally at various stages from planning to completion. Although some attempts were made to standardize study designs, this was hindered by the ferocity of the pandemic and the need to set up clinical trials quickly. We take the view that a successful treatment of COVID‐19 patients (i) increases the probability of a recovery or improvement within a certain time interval, say 28 days; (ii) aims to expedite favorable events within this time frame; and (iii) does not increase mortality over this time period. On this background, we discuss the choice of endpoint and its analysis. Furthermore, we consider consequences of this choice for other design aspects including sample size and power and provide some guidance on the application of adaptive designs in this particular context. John Wiley and Sons Inc. 2021-10-22 2022-03 /pmc/articles/PMC8653377/ /pubmed/34677829 http://dx.doi.org/10.1002/bimj.202000359 Text en © 2021 The Authors. Biometrical Journal published by Wiley‐VCH GmbH. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Trial Design and Methodology
Beyersmann, Jan
Friede, Tim
Schmoor, Claudia
Design aspects of COVID‐19 treatment trials: Improving probability and time of favorable events
title Design aspects of COVID‐19 treatment trials: Improving probability and time of favorable events
title_full Design aspects of COVID‐19 treatment trials: Improving probability and time of favorable events
title_fullStr Design aspects of COVID‐19 treatment trials: Improving probability and time of favorable events
title_full_unstemmed Design aspects of COVID‐19 treatment trials: Improving probability and time of favorable events
title_short Design aspects of COVID‐19 treatment trials: Improving probability and time of favorable events
title_sort design aspects of covid‐19 treatment trials: improving probability and time of favorable events
topic Trial Design and Methodology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8653377/
https://www.ncbi.nlm.nih.gov/pubmed/34677829
http://dx.doi.org/10.1002/bimj.202000359
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