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Multiplicity adjustments in parallel-group multi-arm trials sharing a control group: Clear guidance is needed

Molloy, SF; White, IR; Nunn, AJ; Hayes, R; Wang, D; Harrison, TS; (2022) Multiplicity adjustments in parallel-group multi-arm trials sharing a control group: Clear guidance is needed. Contemporary Clinical Trials , 113 , Article 106656. 10.1016/j.cct.2021.106656. Green open access

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Abstract

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.

Type: Article
Title: Multiplicity adjustments in parallel-group multi-arm trials sharing a control group: Clear guidance is needed
Location: United States
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.cct.2021.106656
Publisher version: https://doi.org/10.1016/j.cct.2021.106656
Language: English
Additional information: © 2021 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Keywords: Multi-arm, parallel-group clinical trials, Multiplicity, Type 1 error, Family-wise error rate (FWER)
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
URI: https://discovery.ucl.ac.uk/id/eprint/10141136
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