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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...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2021
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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. |
format | Online Article Text |
id | pubmed-8653377 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
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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