Yates, Tom A;
Barnes, Samara;
Dedicoat, Martin;
Kon, Onn Min;
Kunst, Heinke;
Lipman, Marc;
Millington, Kerry A;
... UK Academics and Professionals to end TB; + view all
(2024)
Drug-resistant tuberculosis treatments, the case for a phase III platform trial.
Bull World Health Organ
, 102
(9)
pp. 657-664.
10.2471/BLT.23.290948.
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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.
| Type: | Article |
|---|---|
| Title: | Drug-resistant tuberculosis treatments, the case for a phase III platform trial |
| Location: | Switzerland |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.2471/BLT.23.290948 |
| Publisher version: | http://dx.doi.org/10.2471/blt.23.290948 |
| Language: | English |
| Additional information: | © 2024 The authors; licensee World Health Organization. This is an open access article distributed under the terms of the Creative Commons Attribution IGO License (http://creativecommons.org/licenses/by/3.0/igo/legalcode), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. In any reproduction of this article there should not be any suggestion that WHO or this article endorse any specific organization or products. The use of the WHO logo is not permitted. This notice should be preserved along with the article’s original URL. |
| Keywords: | Humans, Tuberculosis, Multidrug-Resistant, Antitubercular Agents, Clinical Trials, Phase III as Topic, Diarylquinolines |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Infection and Immunity UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10196845 |
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