A new clinical trial by the UCT Lung Institute's Centre for TB Research Innovation (CTBRI) is not only innovative in design and in its collaborative nature, but it's also the first major African TB study to use a complete source-based electronic data capture and verification system.
Importantly, the clinical trial will identify new TB treatment regimens, part of an international 'common research' initiative to significantly shorten the duration of treatment from six to three months.
The trial is recruiting patients from City of Cape Town clinics and these patients on novel TB treatment combinations will be followed up intensively for a year. A second site operates from TASK Applied Science in Bellville.
The African Consortium for the Evaluation of Anti-tuberculosis agents (PanACEA) has been developing capacity by building infrastructure and supporting the professional development of African and European scientists. The PanACEA network includes 11 African institutions in six countries linked with four European Institutions.
Funded by the European Developing Country Clinical Trials Partnership (EDCTP), the Multi-arm-multi-stage-TB (MAMS-TB) trial uses a combination of established and novel TB drugs. This initiative addresses constraints to new drug development where a 'brokered call' across African sites offers a more efficient approach.
The aim is to develop a portfolio of new TB treatment combinations, free of political or commercial constraints, and to develop a network of African trial centres large enough to host pivotal phase III trials, says Dr Rod Dawson, CTBRI research unit head and a principal investigator in the PanACEA trial.
Scientists working on the development of different anti-TB drugs have agreed to work together for a uniform approach. This will also facilitate future trials where drugs can 'cross over' from one project to another to improve the efficacy of combined TB treatment regimens.
The PanACEA consortium operates under the auspices of the EDCTP. The EDCTP's target is poverty-related diseases such as HIV/AIDS, malaria and tuberculosis. Focusing on phase II and III clinical trials, the EDCTP has become a catalyst for innovative trials and for successful scientific capacity development programmes. It now supports some 200 projects around the world.
"Conventional market solutions to tuberculosis drug development cannot be expected to provide the whole answer," said Dawson.
Using the MAMS study design, treatments that might result in unfavourable outcomes can be dropped quickly. This allows researchers to test multiple potential treatments rapidly, to select the best combination for trial and obtain approval from the licensing authorities.
Ludwig-Maximilians-University of Munich is sponsoring the study.
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