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Drug-resistant tuberculosis clinical trials: Proposed core research definitions in adults

Furin, J; Alirol, E; Allen, E; Fielding, K; Merle, C; Abubakar, I; Andersen, J; ... Du Cros, P; + view all (2016) Drug-resistant tuberculosis clinical trials: Proposed core research definitions in adults. International Journal of Tuberculosis and Lung Disease , 20 (3) pp. 290-294. 10.5588/ijtld.15.0490. Green open access

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Abstract

Drug-resistant tuberculosis (DR-TB) is a growing public health problem, and for the first time in decades, new drugs for the treatment of this disease have been developed. These new drugs have prompted strengthened efforts in DR-TB clinical trials research, and there are now multiple ongoing and planned DR-TB clinical trials. To facilitate comparability and maximise policy impact, a common set of core research definitions is needed, and this paper presents a core set of efficacy and safety definitions as well as other important considerations in DR-TB clinical trials work. To elaborate these definitions, a search of clinical trials registries, published manuscripts and conference proceedings was undertaken to identify groups conducting trials of new regimens for the treatment of DR-TB. Individuals from these groups developed the core set of definitions presented here. Further work is needed to validate and assess the utility of these definitions but they represent an important first step to ensure there is comparability in clinical trials on multidrug-resistant TB.

Type: Article
Title: Drug-resistant tuberculosis clinical trials: Proposed core research definitions in adults
Open access status: An open access version is available from UCL Discovery
DOI: 10.5588/ijtld.15.0490
Publisher version: http://dx.doi.org/10.5588/ijtld.15.0490
Language: English
Additional information: Copyright © The Union 2016.
Keywords: definitions; drug-resistant tuberculosis; research
UCL classification: UCL
UCL > Provost and Vice Provost Offices
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
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
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health
URI: https://discovery.ucl.ac.uk/id/eprint/1476306
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