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Fig. 3 | BMC Infectious Diseases

Fig. 3

From: A comparison of clinical development pathways to advance tuberculosis regimen development

Fig. 3

Seamless MAMS interim timing and criteria optimization A Fraction of simulations graduated for Seamless MAMS trials with second interim criteria fixed at relapse rate < 12% while exploring second interim timing. The control in grey, represents the proportion of simulations in which the trial was not stopped prematurely due to all investigational arms being stopped. B Fraction of simulations graduated for Seamless MAMS trials with second interim timing fixed at 200 patients per arm while exploring second interim criteria. Dotted line represents selected optimized second interim conditions, where an interim timing of 200 patients per arm is the earliest timing in which the risk of stopping the desirable regimen is negligible and an interim criteria of relapse rate < 12% is the strictest criteria in which the risk of stopping the desirable regimen is negligible. C Fraction of arms stopped in interim 1 and 2. Note that interim 2 can distinguish between different durations of the same regimen, whereas interim 1 cannot

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