title: Drug-resistant tuberculosis clinical trials: proposed core research definitions in adults.
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.
authors.affiliation: TB Research Unit, Case Western Reserve University School of Medicine, Room E-202, 2210 Circle Dr, Cleveland, OH 44149, USA. jjf38@case.edu.
authors.forename: J
authors.initials: J
authors.lastname: Furin
authors.affiliation: Manson Unit Médicins Sans Frontières, London, UK.
authors.forename: E
authors.initials: E
authors.lastname: Alirol
authors.affiliation: Infectious Diseases, London School of Hygiene & Tropical Medicine, London, UK.
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authors.initials: E
authors.lastname: Allen
authors.affiliation: Infectious Diseases, London School of Hygiene & Tropical Medicine, London, UK.
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authors.lastname: Fielding
authors.affiliation: Infectious Diseases, London School of Hygiene & Tropical Medicine, London, UK.
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authors.lastname: Merle
authors.affiliation: Department of Infection and Population Health, University College of London, London, UK.
authors.forename: I
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authors.lastname: Abubakar
authors.affiliation: Statistical and Data Analysis Center, Harvard School of Public Health, Boston, Massachusetts, USA.
authors.forename: J
authors.initials: J
authors.lastname: Andersen
authors.affiliation: Institutes of Infection and Global Health and of Translational Medicine, University of Liverpool, Liverpool, UK.
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authors.lastname: Davies
authors.affiliation: Department of Medicine, University of Cape Town, Groote Schuur Hospital, Cape Town, South Africa.
authors.forename: K
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authors.lastname: Dheda
authors.affiliation: Biomedical Sciences, Faculty of Health Sciences, University of Stellenbosch, Tygerberg, South Africa.
authors.forename: A
authors.initials: A
authors.lastname: Diacon
authors.affiliation: Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.
authors.forename: K E
authors.initials: KE
authors.lastname: Dooley
authors.affiliation: Tuberculosis Foundation, KNCV, Amsterdam, The Netherlands.
authors.forename: G
authors.initials: G
authors.lastname: Dravnice
authors.affiliation: Pathology and Microbiology, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.
authors.forename: K
authors.initials: K
authors.lastname: Eisenach
authors.affiliation: Global Alliance for TB Drug Development, New York, New York, USA.
authors.forename: D
authors.initials: D
authors.lastname: Everitt
authors.affiliation: Sequella, Rockville, Maryland, USA.
authors.forename: D
authors.initials: D
authors.lastname: Ferstenberg
authors.affiliation: TB Unit, University of Limpopo, Sovenga, South Africa.
authors.forename: A
authors.initials: A
authors.lastname: Goolam-Mahomed
authors.affiliation: Department of Infectious Diseases, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: M P
authors.initials: MP
authors.lastname: Grobusch
authors.affiliation: Otsuka USA, Rockville, Maryland, USA.
authors.forename: R
authors.initials: R
authors.lastname: Gupta
authors.affiliation: TB Research Unit, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
authors.forename: E
authors.initials: E
authors.lastname: Harausz
authors.affiliation: Treatment Action Group, New York City, New York, USA.
authors.forename: M
authors.initials: M
authors.lastname: Harrington
authors.affiliation: Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts, USA.
authors.forename: C R
authors.initials: CR
authors.lastname: Horsburgh
authors.affiliation: Stop TB Partnership & Stop TB Department, World Health Organization, Geneva, Switzerland.
authors.forename: C
authors.initials: C
authors.lastname: Lienhardt
authors.affiliation: Medical Service Corp International, Arlington, Virginia, USA.
authors.forename: D
authors.initials: D
authors.lastname: McNeeley
authors.affiliation: Department of Global Health & Social Medicine, Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: C D
authors.initials: CD
authors.lastname: Mitnick
authors.affiliation: Department of Pediatrics, Stony Brook School of Medicine, Stony Brook, New York, USA.
authors.forename: S
authors.initials: S
authors.lastname: Nachman
authors.affiliation: Curry International Tuberculosis Center, San Francisco General Hospital, University of California San Francisco, San Francisco, California, USA.
authors.forename: P
authors.initials: P
authors.lastname: Nahid
authors.affiliation: Medical Research Council Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, London, UK.
authors.forename: A J
authors.initials: AJ
authors.lastname: Nunn
authors.affiliation: Medical Research Council Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, London, UK.
authors.forename: P
authors.initials: P
authors.lastname: Phillips
authors.affiliation: Department of Respiratory Medicine, P D Hinduja National Hospital and Medical Research Centre, Mumbai, India.
authors.forename: C
authors.initials: C
authors.lastname: Rodriguez
authors.affiliation: Department of Global Health & Social Medicine, Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: S
authors.initials: S
authors.lastname: Shah
authors.affiliation: Otsuka USA, Rockville, Maryland, USA.
authors.forename: C
authors.initials: C
authors.lastname: Wells
authors.affiliation: Manson Unit Médicins Sans Frontières, London, UK.
authors.forename: B
authors.initials: B
authors.lastname: Thomas-Nyang'wa
authors.affiliation: Manson Unit Médicins Sans Frontières, London, UK.
authors.forename: P
authors.initials: P
authors.lastname: du Cros
mesh_terms: D000328:Adult; D000995:Antitubercular Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D006801:Humans; D009169:Mycobacterium tuberculosis / Q000187:drug effects; D012107:Research Design / Q000592:standards*; D018088:Tuberculosis, Multidrug-Resistant / Q000188:drug therapy*
chemical_list: D000995:Antitubercular Agents