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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 ORCID: https://orcid.org/0000-0003-2788-2464 and Harrison, Thomas S. (2022) 'Multiplicity adjustments in parallel-group multi-arm trials sharing a control group: Clear guidance is needed'. Contemporary Clinical Trials, Vol 113, e106656.

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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.

Item Type: Article
Subjects: QV Pharmacology > Drug Standardization. Pharmacognosy. Medicinal Plants > QV 771 Standardization and evaluation of drugs
W General Medicine. Health Professions > W 20.5 Biomedical research
Faculty: Department: Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI): https://doi.org/10.1016/j.cct.2021.106656
Depositing User: Lynn Roberts-Maloney
Date Deposited: 07 Jul 2022 10:31
Last Modified: 07 Jul 2022 10:31
URI: https://archive.lstmed.ac.uk/id/eprint/20712

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