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Journal Article > Research

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

Furin J, Alirol E, Allen E, Fielding K, Merle CS, Abubakar I, Andersen J, Davies G, Dheda K, Diacon A, Dooley KE, Dravnice G, Eisenach K, Everitt D, Ferstenberg D, Goolam-Mahomed A, Grobusch MP, Gupta RS, Harausz EP, Harrington M, Horsburgh Jr CR, Lienhardt C, McNeeley D, Mitnick CD, Nachman S, Nahid P, Nunn AJ, Phillips PPJ, Rodriguez CA, Shah SK, Wells C, Nyang'wa BT, du Cros PAK
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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.
Subject Area
antibiotic resistancetuberculosisantimicrobial resistance
DOI
10.5588/ijtld.15.0490
Published Date
01-Mar-2016
PubMed ID
27046707
Languages
English
Journal
International Journal of Tuberculosis and Lung Disease
Volume / Issue / Pages
Volume 20, Issue 3, Pages 290-294
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