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 language | English |
|---|---|
| Article number | 106656 |
| Pages (from-to) | e106656 |
| Journal | Contemporary Clinical Trials |
| Volume | 113 |
| Early online date | 18 Dec 2021 |
| DOIs | |
| Publication status | Published - 1 Feb 2022 |
Keywords
- Family-wise error rate (FWER)
- Multi-arm, parallel-group clinical trials
- Multiplicity
- Type 1 error