title: Accelerating clinical drug development for children with tuberculosis.
abstract: Despite urgent need, the development, approval and availability of child-friendly anti-tuberculosis drugs lag significantly behind that of adults, with children having been ignored in anti-tuberculosis drug development research. This paper outlines possible strategies for accelerating and better integrating the development of drugs and regimens for pediatric tuberculosis (TB) into existing drug development pathways for adults: initiation of pediatric studies of new treatments as soon as promising efficacy data have been generated in adults following successful phase II studies, shifting from the current age de-escalated approach to concomitant enrollment of children from the various age groups in studies, and leveraging the concepts of both the Unified Pathway and regimen development that have helped speed the study and development of novel regimens in adults.
authors.affiliation: The Global Alliance for TB Drug Development, New York, New York.
authors.forename: S
authors.initials: S
authors.lastname: Murray
authors.affiliation: Treatment Action Group, New York, New York, USA.
authors.forename: L
authors.initials: L
authors.lastname: McKenna
authors.affiliation: Office of Anti-infectives and Vaccines, European Medicines Agency, London, UK.
authors.forename: E
authors.initials: E
authors.lastname: Pelfrene
authors.affiliation: Office of Anti-infectives and Vaccines, European Medicines Agency, London, UK.
authors.forename: R
authors.initials: R
authors.lastname: Botgros
mesh_terms: D000995:Antitubercular Agents / Q000008:administration & dosage*; D002626:Chemistry, Pharmaceutical / Q000191:economics*; D002648:Child; D017322:Clinical Trials, Phase II as Topic; D006801:Humans; D010372:Pediatrics; D014376:Tuberculosis / Q000188:drug therapy*
chemical_list: D000995:Antitubercular Agents