Towards Early Inclusion of Children in Tuberculosis Drugs Trials: A Consensus Statement

Hdl Handle:
http://hdl.handle.net/10144/575408
Title:
Towards Early Inclusion of Children in Tuberculosis Drugs Trials: A Consensus Statement
Authors:
Nachman, S; Ahmed, A; Amanullah, F; Becerra, M C; Botgros, R; Brigden, G; Browning, R; Gardiner, E; Hafner, R; Hesseling, A; How, C; Jean-Philippe, P; Lessem, E; Makhene, M; Mbelle, N; Marais, B; McIlleron, H; McNeeley, D F; Mendel, C; Murray, S; Navarro, E; Anyalechi, E G; Porcalla, A R; Powell, C; Powell, M; Rigaud, M; Rouzier, V; Samson, P; Schaaf, H S; Shah, S; Starke, J; Swaminathan, S; Wobudeya, E; Worrell, C
Journal:
Lancet Infectious Diseases
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 effective, are hampered by high pill burden, long duration of treatment, coexistent toxic effects, 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.
Publisher:
Elsevier
Issue Date:
Jun-2015
URI:
http://hdl.handle.net/10144/575408
DOI:
10.1016/S1473-3099(15)00007-9
PubMed ID:
25957923
Language:
en
ISSN:
1474-4457
Appears in Collections:
TB

Full metadata record

DC FieldValue Language
dc.contributor.authorNachman, Sen_GB
dc.contributor.authorAhmed, Aen_GB
dc.contributor.authorAmanullah, Fen_GB
dc.contributor.authorBecerra, M Cen_GB
dc.contributor.authorBotgros, Ren_GB
dc.contributor.authorBrigden, Gen_GB
dc.contributor.authorBrowning, Ren_GB
dc.contributor.authorGardiner, Een_GB
dc.contributor.authorHafner, Ren_GB
dc.contributor.authorHesseling, Aen_GB
dc.contributor.authorHow, Cen_GB
dc.contributor.authorJean-Philippe, Pen_GB
dc.contributor.authorLessem, Een_GB
dc.contributor.authorMakhene, Men_GB
dc.contributor.authorMbelle, Nen_GB
dc.contributor.authorMarais, Ben_GB
dc.contributor.authorMcIlleron, Hen_GB
dc.contributor.authorMcNeeley, D Fen_GB
dc.contributor.authorMendel, Cen_GB
dc.contributor.authorMurray, Sen_GB
dc.contributor.authorNavarro, Een_GB
dc.contributor.authorAnyalechi, E Gen_GB
dc.contributor.authorPorcalla, A Ren_GB
dc.contributor.authorPowell, Cen_GB
dc.contributor.authorPowell, Men_GB
dc.contributor.authorRigaud, Men_GB
dc.contributor.authorRouzier, Ven_GB
dc.contributor.authorSamson, Pen_GB
dc.contributor.authorSchaaf, H Sen_GB
dc.contributor.authorShah, Sen_GB
dc.contributor.authorStarke, Jen_GB
dc.contributor.authorSwaminathan, Sen_GB
dc.contributor.authorWobudeya, Een_GB
dc.contributor.authorWorrell, Cen_GB
dc.date.accessioned2015-08-20T18:29:11Z-
dc.date.available2015-08-20T18:29:11Z-
dc.date.issued2015-06-
dc.identifier.citationTowards early inclusion of children in tuberculosis drugs trials: a consensus statement. 2015, 15 (6):711-20 Lancet Infect Disen_GB
dc.identifier.issn1474-4457-
dc.identifier.pmid25957923-
dc.identifier.doi10.1016/S1473-3099(15)00007-9-
dc.identifier.urihttp://hdl.handle.net/10144/575408-
dc.description.abstractChildren 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 effective, are hampered by high pill burden, long duration of treatment, coexistent toxic effects, 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_GB
dc.language.isoenen
dc.publisherElsevieren_GB
dc.rightsArchived with thanks to The Lancet. Infectious Diseasesen_GB
dc.subject.meshAdolescenten_GB
dc.subject.meshAdulten_GB
dc.subject.meshAge Factorsen_GB
dc.subject.meshAntitubercular Agentsen_GB
dc.subject.meshChilden_GB
dc.subject.meshChild, Preschoolen_GB
dc.subject.meshClinical Trials as Topicen_GB
dc.subject.meshConsensusen_GB
dc.subject.meshFemaleen_GB
dc.subject.meshHumansen_GB
dc.subject.meshInfanten_GB
dc.subject.meshInfant, Newbornen_GB
dc.subject.meshMaleen_GB
dc.subject.meshTuberculosisen_GB
dc.titleTowards Early Inclusion of Children in Tuberculosis Drugs Trials: A Consensus Statementen
dc.identifier.journalLancet Infectious Diseasesen_GB

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