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;
(2021)
Multiplicity adjustments in parallel-group multi-arm trials sharing a control group: Clear guidance is needed.
CONTEMPORARY CLINICAL TRIALS, 113.
106656-.
ISSN 1551-7144
DOI: 10.1016/j.cct.2021.106656
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 |
---|---|
Elements ID | 168990 |
ORCID: https://orcid.org/0000-0002-1729-9892