Abstract
Background Tuberculosis (TB) causes significant morbidity and mortality globally. High efficacy in clinical trials of the current 4-drug 6-month regimen does not always translate into practice due to a heavy pill burden and long duration. New drugs are in late-phase clinical development, so trials that evaluate novel and existing drugs in combination are urgently needed. A multi-arm multi-stage (MAMS) design, with planned interim analyses allowing stopping of arms not showing benefit, has been developed and used in oncology. We have adapted this approach to create the PanACEA MAMS-TB 5-arm 3-stage phase II trial evaluating new treatments for TB.
Highlights
Tuberculosis (TB) causes significant morbidity and mortality globally
New drugs are in late-phase clinical development, so trials that evaluate novel and existing drugs in combination are urgently needed
A multi-arm multi-stage (MAMS) design, with planned interim analyses allowing stopping of arms not showing benefit, has been developed and used in oncology
Summary
Modifying the multi-arm multi-stage (MAMS) design for use in a phase II tuberculosis trial in sub-Saharan Africa with a time-to-event primary outcome. Patrick Phillips4*, Michael Hoelscher, Daniel Bratton, Sunita Rehal, Norbert Heinrich, Georgette Plemper van Balen, Andrew Nunn, Rob Aarnoutse, Sonja Henne, Stephen Gillespie, Martin Boeree, PanACEA consortium. From 2nd Clinical Trials Methodology Conference: Methodology Matters Edinburgh, UK. From 2nd Clinical Trials Methodology Conference: Methodology Matters Edinburgh, UK. 18-19 November 2013
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