Free Content Requirements for the clinical evaluation of new anti-tuberculosis agents in children

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Abstract:

The ultimate goal of evidence-based drug treatment is to produce a desired pharmacological response in a predictable manner and also to minimise adverse effects. This goal requires not only an increased awareness of the need to provide specific dosing recommendations aimed at specific patient groups, but also the implementation of a consistent integrative approach to recognise all factors contributing to the within- and between-subject variability in drug disposition and response. The assessment of new anti-tuberculosis agents and regimens in children requires a specific programme of investigation, and should be included early in human drug evaluation programmes. Appreciation of this principle is an important step forward towards the full integration of children into the tuberculosis research agenda and control programmes. The development of anti-tuberculosis drug formulations and regimens tailored to the requirements of children needs to consider physiological age-related differences for pharmacokinetics and toxicity between adults and children. Research based on these principles will create an evidence base that will inform the appropriate treatment of children with novel agents and regimens and will also inform future research, including the use of chemoprophylaxis and treatment-shortening strategies in children.

Keywords: children; drugs; evaluation; framework; requirements; tuberculosis

Document Type: Research Article

DOI: http://dx.doi.org/10.5588/ijtld.12.0567

Affiliations: 1: Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa 2: Center for Pediatric Research, Carolinas Medical Center, Charlotte, North Carolina, USA; and University of North Carolina, Chapel Hill, North Carolina, USA 3: Infectious Diseases Clinic of Denver Public Health, Denver Health Hospital, Denver, Colorado, USA 4: Children's Infectious Diseases Clinical Research Unit, Department of Paediatrics and Child Health, Faculty of Health Sciences, Stellenbosch University, Cape Town, South Africa 5: Centre for International Child Health, University of Melbourne Department of Paediatrics, Royal Children's Hospital, Parkville, Victoria, Australia 6: The Global Alliance for TB Drug Development, New York, New York, USA 7: Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa 8: Tuberculosis Trials Consortium, Clinical Research Branch, Division of Tuberculosis Elimination, Centers for Disease Control and Prevention, Atlanta, Georgia, USA 9: Department of Pediatrics, Health Science Center, State University of New York at Stony Brook, Stony Brook, New York, USA 10: Baylor College of Medicine, Houston, Texas, USA 11: TB/HIV Project, Treatment Action Group, New York, New York, USA

Publication date: June 1, 2013

More about this publication?
  • 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 tuberculosis and lung health world-wide.

    Certain IJTLD articles are selected for translation into French, Spanish, Chinese or Russian. They are available on the Union website

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