Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Molloy, Síle F., White, Ian R., Nunn, Andrew J., Hayes, Richard, Wang, Duolao, Harrison, Thomas S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2022
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
_version_ 1784651511045816320
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
work_keys_str_mv AT molloysilef multiplicityadjustmentsinparallelgroupmultiarmtrialssharingacontrolgroupclearguidanceisneeded
AT whiteianr multiplicityadjustmentsinparallelgroupmultiarmtrialssharingacontrolgroupclearguidanceisneeded
AT nunnandrewj multiplicityadjustmentsinparallelgroupmultiarmtrialssharingacontrolgroupclearguidanceisneeded
AT hayesrichard multiplicityadjustmentsinparallelgroupmultiarmtrialssharingacontrolgroupclearguidanceisneeded
AT wangduolao multiplicityadjustmentsinparallelgroupmultiarmtrialssharingacontrolgroupclearguidanceisneeded
AT harrisonthomass multiplicityadjustmentsinparallelgroupmultiarmtrialssharingacontrolgroupclearguidanceisneeded