Towards early inclusion of children in tuberculosis drugs trials : a consensus statement

Show simple item record Nachman, Sharon Ahmed, Amina Amanullah, Farhana Becerra, Mercedes C. Botgros, Radu Brigden, Grania Browning, Renee Gardiner, Elizabeth Hafner, Richard Hesseling, Anneke How, Cleotilde Jean-Philippe, Patrick Lessem, Erica Makhene, Mamodikoe Mbelle, Nontombi Marylucy Marais, Ben McIlleron, Helen McNeeley, David F. Mendel, Carl Murray, Stephen Navarro, Eileen Anyalechi, E. Gloria Porcalla, Ariel R. Powell, Clydette Powell, Mair Rigaud, Mona Rouzier, Vanessa Samson, Pearl Schaaf, H. Simon Shah, Seema Starke, Jeff Swaminathan, Soumya Wobudeya, Eric Worrell, Carol 2015-07-01T05:27:06Z 2015-07-01T05:27:06Z 2015-06
dc.description.abstract Children younger than 18 years account for a substantial proportion of patients with tuberculosis worldwide. Available treatments for paediatric drug-susceptible and drug-resistant tuberculosis, albeit generally eff ective, are hampered by high pill burden, long duration of treatment, coexistent toxic eff ects, and an overall scarcity of suitable child-friendly formulations. Several new drugs and regimens with promising activity against both drug-susceptible and drug-resistant strains have entered clinical development and are either in various phases of clinical investigation or have received marketing authorisation for adults; however, none have data on their use in children. This consensus statement, generated from an international panel of opinion leaders on childhood tuberculosis and incorporating reviews of published literature from January, 2004, to May, 2014, addressed four key questions: what drugs or regimens should be prioritised for clinical trials in children? Which populations of children are high priorities for study? When can phase 1 or 2 studies be initiated in children? What are the relevant elements of clinical trial design? The consensus panel found that children can be included in studies at the early phases of drug development and should be an integral part of the clinical development plan, rather than studied after regulatory approval in adults is obtained. en_ZA
dc.description.embargo 2016-06-30 en_ZA
dc.description.librarian hb2015 en_ZA
dc.description.sponsorship National Institute of Allergy and Infectious Diseases and National Institute of Health.Department of Health and Human Services. en_ZA
dc.description.uri en_ZA
dc.identifier.citation Nachman, S, Ahmed, A, Amanullah, F, Becerra, MC et al 2015, 'Towards early inclusion of children in tuberculosis drugs trials : a consensus statement', Lancet Infectious Diseases, vol. 15, no. 6, pp. 711-720. en_ZA
dc.identifier.issn 1473-3099 (print)
dc.identifier.issn 1474-4457 (online)
dc.identifier.other 10.1016/S1473-3099(15)00007-9
dc.language.iso en en_ZA
dc.publisher Elsevier en_ZA
dc.rights © 2015 Elsevier Ltd. All rights reserved. Notice : this is the author’s version of a work that was accepted for publication in Lancet Infectious Diseases. Changes resulting from the publishing process, such as peer review, editing, corrections, structural formatting, and other quality control mechanisms may not be reflected in this document. Changes may have been made to this work since it was submitted for publication. A definitive version was subsequently published in Lancet Infectious Diseases, vol. 15, no.6, pp. 711-720, 2015. doi :10.1016/S1473-3099(15)00007-9 en_ZA
dc.subject Children en_ZA
dc.subject Tuberculosis drugs trials en_ZA
dc.subject Tuberculosis (TB) en_ZA
dc.subject Paediatric drug-susceptible tuberculosis en_ZA
dc.subject Drug-resistant tuberculosis (DR-TB) en_ZA
dc.subject Childhood tuberculosis en_ZA
dc.title Towards early inclusion of children in tuberculosis drugs trials : a consensus statement en_ZA
dc.type Postprint Article en_ZA

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