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Open Access Methodological considerations in clinical trials for new MDR-TB treatment regimens

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In contrast to the treatment of drug-susceptible tuberculosis (TB), the evidence base underpinning global guidelines for the treatment of multidrug-resistant (MDR) TB is very poor. This, combined with the lack of experience from previous trials and the nature of the disease, means that a number of methodological aspects are specific only to trials for new MDR-TB regimens. These aspects include the weight of evidence required to change policy and practice, the flexibility to make adaptations to an ongoing trial, the choice of patient population, the importance of internal control, the duration and frequency of follow-up, and safety monitoring of novel combinations of new and repurposed drugs.
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Keywords: MDR-TB; clinical trials; evidence-based medicine; methodology

Document Type: Research Article

Affiliations: Medical Research Council Clinical Trials Unit, University College London, London, UK

Publication date: December 1, 2016

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  • The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on tuberculosis and lung health world-wide.

    Certain IJTLD articles are selected for translation into French, Spanish, Chinese or Russian. They are available on the Union website

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