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

J Furin¹, E Alirol², E Allen³, K Fielding³, C Merle³, I Abubakar⁴, J Andersen⁵, G Davies⁶, K Dheda⁷, A Diacon⁸, K E Dooley⁹, G Dravnice¹⁰, K Eisenach¹¹, D Everitt¹², D Ferstenberg¹³, A Goolam-Mahomed¹⁴, M P Grobusch¹⁵, R Gupta¹⁶, E Harausz¹⁷, M Harrington¹⁸, C R Horsburgh¹⁹, C Lienhardt²⁰, D McNeeley²¹, C D Mitnick²², S Nachman²³, P Nahid²⁴, A J Nunn²⁵, P Phillips²⁵, C Rodriguez²⁶, S Shah²², C Wells¹⁶, B Thomas-Nyang'wa², P du Cros²

Affiliations

¹ TB Research Unit, Case Western Reserve University School of Medicine, Room E-202, 2210 Circle Dr, Cleveland, OH 44149, USA. jjf38@case.edu.
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.

PMID: 27046707
PMCID: PMC4843774
DOI: 10.5588/ijtld.15.0490

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

J Furin et al. Int J Tuberc Lung Dis. 2016 Mar.

. 2016 Mar;20(3):290-4.

doi: 10.5588/ijtld.15.0490.

Authors

Affiliations

¹ TB Research Unit, Case Western Reserve University School of Medicine, Room E-202, 2210 Circle Dr, Cleveland, OH 44149, USA. jjf38@case.edu.
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.

PMID: 27046707
PMCID: PMC4843774
DOI: 10.5588/ijtld.15.0490

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.

PubMed Disclaimer

References

1. World Health Organization. Global Tuberculosis Report 2014 (WHO/HTM/TB/2014.08) Geneva: World Health Organization; 2014.
1. Zumla A, Schito M, Maeurer M. Advancing the portfolio of tuberculosis diagnostics, drugs, biomarkers and vaccines. The Lancet Infectious Diseases. 2014;14(4):267–269. - PubMed
1. Zumla A, Gillespie S, Hoelscher M, et al. New antituberculosis drugs, regimens, and adjunct therapies: needs, advances and future prospects. The Lancet Infectious Diseases. 2014 Mar 24;:49–62. http://dx.doi.org/10.1016/. - PubMed
1. Brigden G, Thomas-Nyanga B, duCross P, et al. Principles for designing future regimens for multidrug-resistant tuberculosis. Bulletin of the World Health Organization. 2013;92:68–74. - PMC - PubMed
1. U.S. Food and Drug Administration. Guidance for Industry Pulmonary Tuberculosis: Developing Drugs for Treatment. Draft Guidance. 2013 Nov; http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformati....

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

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

Affiliations

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

Authors

Affiliations

Abstract

References

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical