Bratton, DJ; Phillips, PP; Parmar, MK; (2013) A multi-arm multi-stage clinical trial design for binary outcomes with application to tuberculosis. BMC Medical Research Methodology , 13 , Article 139. 10.1186/1471-2288-13-139.

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Abstract

Randomised controlled trials are becoming increasingly costly and time-consuming. In 2011, Royston and colleagues proposed a particular class of multi-arm multi-stage (MAMS) designs intended to speed up the evaluation of new treatments in phase II and III clinical trials. Their design, which controls the type I error rate and power for each pairwise comparison, discontinues randomisation to poorly performing arms at interim analyses if they fail to show a pre-specified level of benefit over the control arm. Arms in which randomisation is continued to the final stage of the trial are compared against the control on a definitive time-to-event outcome measure. To increase efficiency, interim comparisons can be made on an intermediate time-to-event outcome which is on the causal pathway to the definitive outcome.

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