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

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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.
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Keywords: definitions; drug-resistant tuberculosis; research

Document Type: Research Article

Affiliations: 1: TB Research Unit, Case Western Reserve University School of Medicine, Room E-202, 2210 Circle Dr, Cleveland, OH 44149, USA. [email protected] 2: Manson Unit Médicins Sans Frontières, London, UK 3: Infectious Diseases, London School of Hygiene & Tropical Medicine, London, UK 4: Department of Infection and Population Health, University College of London, London, UK 5: Statistical and Data Analysis Center, Harvard School of Public Health, Boston, Massachusetts, USA 6: Institutes of Infection and Global Health and of Translational Medicine, University of Liverpool, Liverpool, UK 7: Department of Medicine, University of Cape Town, Groote Schuur Hospital, Cape Town, South Africa 8: Biomedical Sciences, Faculty of Health Sciences, University of Stellenbosch, Tygerberg, South Africa 9: Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA 10: Tuberculosis Foundation, KNCV, Amsterdam, The Netherlands 11: Pathology and Microbiology, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA 12: Global Alliance for TB Drug Development, New York, New York, USA 13: Sequella, Rockville, Maryland, USA 14: TB Unit, University of Limpopo, Sovenga, South Africa 15: Department of Infectious Diseases, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands 16: Otsuka USA, Rockville, Maryland, USA 17: TB Research Unit, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA 18: Treatment Action Group, New York City, New York, USA 19: Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts, USA 20: Stop TB Partnership & Stop TB Department, World Health Organization, Geneva, Switzerland 21: Medical Service Corp International, Arlington, Virginia, USA 22: Department of Global Health & Social Medicine, Harvard Medical School, Boston, Massachusetts, USA 23: Department of Pediatrics, Stony Brook School of Medicine, Stony Brook, New York, USA 24: Curry International Tuberculosis Center, San Francisco General Hospital, University of California San Francisco, San Francisco, California, USA 25: Medical Research Council Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, London, UK 26: Department of Respiratory Medicine, P D Hinduja National Hospital and Medical Research Centre, Mumbai, India

Publication date: March 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 lung health world-wide.

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