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

Síle F. Molloy, Ian R. White, Andrew J. Nunn, Richard Hayes, Duolao Wang, Thomas S. Harrison

Research output: Contribution to journalArticlepeer-review

15 Citations (Scopus)

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.

Original languageEnglish
Article number106656
Pages (from-to)e106656
JournalContemporary Clinical Trials
Volume113
Early online date18 Dec 2021
DOIs
Publication statusPublished - 1 Feb 2022

Keywords

  • Family-wise error rate (FWER)
  • Multi-arm, parallel-group clinical trials
  • Multiplicity
  • Type 1 error

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