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.
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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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