With new drugs being developed to shorten and improve the treatment of tuberculosis, it is necessary to evaluate a number of different combinations of new and existing drugs in clinical trials. The Multi-Arm Multi-Stage (MAMS) design allows for several different treatment regimens to be evaluated against the standard regimen for TB in a single trial. At planned intervals during the trial, interim analyses are conducted and poorly performing regimens can be dropped using decisions rules that are pre-specified in the protocol. In this way poor regimens are dropped early in the trial and only those that perform better than pre-specified thresholds are continued for evaluation against the common control.
With a MAMS design, multiple regimens can be evaluated simultaneously using smaller patient numbers and fewer resources allowing for shorter, safer and more effective regimens to move sooner into clinical practice.
Fuller discussion of innovative trials designs, including the MAMS design, can be found in the paper authored by partners in the PanACEA consortium:
Innovative trial designs are practical solutions for improving the treatment of tuberculosis. Phillips PP, Gillespie SH, Boeree M, Heinrich N, Aarnoutse R, McHugh T, Pletschette M, Lienhardt C, Hafner R, Mgone C, Zumla A, Nunn AJ, Hoelscher M. Journal of Infectious Diseases, 2012; 205 Suppl 2: S250-7.