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Publication Detail
Multiplicity adjustments in parallel-group multi-arm trials sharing a control group: Clear guidance is needed
  • Publication Type:
    Journal article
  • Publication Sub Type:
    Journal Article
  • Authors:
    Molloy SF, White IR, Nunn AJ, Hayes R, Wang D, Harrison TS
  • Publication date:
    01/02/2022
  • Journal:
    Contemporary Clinical Trials
  • Volume:
    113
  • Status:
    Published
  • Print ISSN:
    1551-7144
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.
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