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Multiplicity adjustments in parallel-group multi-arm trials sharing a control group: Clear guidance is needed
Multi-arm, parallel-group clinical trials are an efficient way of testing several new treatments, treatment regimens or doses. However, guidance on the requirement for statistical adjustment to control for multiple comparisons (type I error) using a shared control group is unclear. We argue, based o...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8844584/ https://www.ncbi.nlm.nih.gov/pubmed/34906747 http://dx.doi.org/10.1016/j.cct.2021.106656 |
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author | Molloy, Síle F. White, Ian R. Nunn, Andrew J. Hayes, Richard Wang, Duolao Harrison, Thomas S. |
author_facet | Molloy, Síle F. White, Ian R. Nunn, Andrew J. Hayes, Richard Wang, Duolao Harrison, Thomas S. |
author_sort | Molloy, Síle F. |
collection | PubMed |
description | Multi-arm, parallel-group clinical trials are an efficient way of testing several new treatments, treatment regimens or doses. However, guidance on the requirement for statistical adjustment to control for multiple comparisons (type I error) using a shared control group is unclear. We argue, based on current evidence, that adjustment is not always necessary in such situations. We propose that adjustment should not be a requirement in multi-arm, parallel-group trials testing distinct treatments and sharing a control group, and we call for clearer guidance from stakeholders, such as regulators and scientific journals, on the appropriate settings for adjustment of multiplicity. |
format | Online Article Text |
id | pubmed-8844584 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-88445842022-02-22 Multiplicity adjustments in parallel-group multi-arm trials sharing a control group: Clear guidance is needed Molloy, Síle F. White, Ian R. Nunn, Andrew J. Hayes, Richard Wang, Duolao Harrison, Thomas S. Contemp Clin Trials Short Communication Multi-arm, parallel-group clinical trials are an efficient way of testing several new treatments, treatment regimens or doses. However, guidance on the requirement for statistical adjustment to control for multiple comparisons (type I error) using a shared control group is unclear. We argue, based on current evidence, that adjustment is not always necessary in such situations. We propose that adjustment should not be a requirement in multi-arm, parallel-group trials testing distinct treatments and sharing a control group, and we call for clearer guidance from stakeholders, such as regulators and scientific journals, on the appropriate settings for adjustment of multiplicity. Elsevier 2022-02 /pmc/articles/PMC8844584/ /pubmed/34906747 http://dx.doi.org/10.1016/j.cct.2021.106656 Text en © 2021 The Authors https://creativecommons.org/licenses/by/4.0/This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Short Communication Molloy, Síle F. White, Ian R. Nunn, Andrew J. Hayes, Richard Wang, Duolao Harrison, Thomas S. Multiplicity adjustments in parallel-group multi-arm trials sharing a control group: Clear guidance is needed |
title | Multiplicity adjustments in parallel-group multi-arm trials sharing a control group: Clear guidance is needed |
title_full | Multiplicity adjustments in parallel-group multi-arm trials sharing a control group: Clear guidance is needed |
title_fullStr | Multiplicity adjustments in parallel-group multi-arm trials sharing a control group: Clear guidance is needed |
title_full_unstemmed | Multiplicity adjustments in parallel-group multi-arm trials sharing a control group: Clear guidance is needed |
title_short | Multiplicity adjustments in parallel-group multi-arm trials sharing a control group: Clear guidance is needed |
title_sort | multiplicity adjustments in parallel-group multi-arm trials sharing a control group: clear guidance is needed |
topic | Short Communication |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8844584/ https://www.ncbi.nlm.nih.gov/pubmed/34906747 http://dx.doi.org/10.1016/j.cct.2021.106656 |
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