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

Phillips, PPJ; (2016) Methodological considerations in clinical trials for new MDR-TB treatment regimens. The International Journal of Tuberculosis and Lung Disease , 20 (S1) S4-S7. 10.5588/ijtld.16.0061. Green open access

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Abstract

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.

Type: Article
Title: Methodological considerations in clinical trials for new MDR-TB treatment regimens
Open access status: An open access version is available from UCL Discovery
DOI: 10.5588/ijtld.16.0061
Publisher version: http://dx.doi.org/10.5588/ijtld.16.0061
Language: English
Additional information: Copyright © 2016 The Union.
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 Population Health Sciences > Institute for Global Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health > Infection and Population Health
URI: https://discovery.ucl.ac.uk/id/eprint/1528765
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