Drug-resistant tuberculosis treatments, the case for a phase III platform trial.
Yates, Tom A Barnes, Samara Dedicoat, Martin
Kon, Onn Min Kunst, Heinke Lipman, Marc Millington, Kerry A Nunn, Andrew J Phillips, Patrick Pj Potter, Jessica L
Yates, Tom A
Barnes, Samara
Kon, Onn Min
Kunst, Heinke
Lipman, Marc
Millington, Kerry A
Nunn, Andrew J
Phillips, Patrick Pj
Potter, Jessica L
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2024-09-01
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Abstract
Most phase III trials in drug-resistant tuberculosis have either been underpowered to quantify differences in microbiological endpoints or have taken up to a decade to complete. Composite primary endpoints, dominated by differences in treatment discontinuation and regimen changes, may mask important differences in treatment failure and relapse. Although new regimens for drug-resistant tuberculosis appear very effective, resistance to new drugs is emerging rapidly. There is a need for shorter, safer and more tolerable regimens, including those active against bedaquiline-resistant tuberculosis. Transitioning from multiple regimen A versus regimen B trials to a single large phase III platform trial would accelerate the acquisition of robust estimates of relative efficacy and safety. Further efficiencies could be achieved by adopting modern adaptive platform designs. Collaboration among trialists, affected community representatives, funders and regulators is essential for developing such a phase III platform trial for drug-resistant tuberculosis treatment regimens.
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Yates TA, Barnes S, Dedicoat M, Kon OM, Kunst H, Lipman M, Millington KA, Nunn AJ, Phillips PP, Potter JL, Squire SB; UK Academics and Professionals to end TB. Drug-resistant tuberculosis treatments, the case for a phase III platform trial. Bull World Health Organ. 2024 Sep 1;102(9):657-664. doi: 10.2471/BLT.23.290948.
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