biostudies-literatureChoodari-Oskooei BMedical Research CouncilNational Institute for Health Research (NIHR)National Institute for Health and Care Research124https://www.ebi.ac.uk/biostudies/studies/S-EPMC11145876biostudies-literatureUnknown24(1)<h4>Background</h4>Multi-arm multi-stage (MAMS) randomised trial designs have been proposed to evaluate multiple research questions in the confirmatory setting. In designs with several interventions, such as the 8-arm 3-stage ROSSINI-2 trial for preventing surgical wound infection, there are likely to be strict limits on the number of individuals that can be recruited or the funds available to support the protocol. These limitations may mean that not all research treatments can continue to accrue the required sample size for the definitive analysis of the primary outcome measure at the final stage. In these cases, an additional treatment selection rule can be applied at the early stages of the trial to restrict the maximum number of research arms that can progress to the subsequent stage(sBMC medical research methodologyMulti-arm multi-stage (MAMS) randomised selection designs: impact of treatment selection rules on the operating characteristics.PMC1114587616/31/123MC_UU_00004/09MC_UU_00004_0916/31/12Handley KChoodari-Oskooei BBlenkinsop AParmar MKBPinkney TfalseMulti-arm multi-stage (MAMS) randomised selection designs: impact of treatment selection rules on the operating characteristics.<h4>Background</h4>Multi-arm multi-stage (MAMS) randomised trial designs have been proposed to evaluate multiple research questions in the confirmatory setting. In designs with several interventions, such as the 8-arm 3-stage ROSSINI-2 trial for preventing surgical wound infection, there are likely to be strict limits on the number of individuals that can be recruited or the funds available to support the protocol. These limitations may mean that not all research treatments can continue to accrue the required sample size for the definitive analysis of the primary outcome measure at the final stage. In these cases, an additional treatment selection rule can be applied at the early stages of the trial to restrict the maximum number of research arms that can progress to the subsequent stage(s2024-01-01T00:00:00Z2024 Jun2026-06-02T06:16:50.411Z2026-04-15T03:15:19.851ZS-EPMC111458763883142110.1186/s12874-024-02247-w