title: Failed Pediatric Drug Development Trials.
abstract: Pediatric product development initiatives have stimulated the development of therapies for children, resulting in improved product labeling, increased identification of adverse events, and development of new pediatric formulations. However, 42% of recently completed pediatric trials have failed to establish either safety or efficacy, leading to an inability to label the product for use in children.(1) Characterizing these failed trials, including common contributing factors, is imperative to designing better pediatric trials in the future.
authors.affiliation: Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, La Jolla, California, USA.
authors.forename: J D
authors.initials: JD
authors.lastname: Momper
authors.affiliation: Pediatric Clinical Pharmacology Staff, Office of Clinical Pharmacology, Office of Translational Sciences, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: Y
authors.initials: Y
authors.lastname: Mulugeta
authors.affiliation: Pediatric Clinical Pharmacology Staff, Office of Clinical Pharmacology, Office of Translational Sciences, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: G J
authors.initials: GJ
authors.lastname: Burckart
mesh_terms: D000367:Age Factors; D002626:Chemistry, Pharmaceutical; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D055808:Drug Discovery / Q000379:methods*; D054796:Drug Dosage Calculations; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D004364:Pharmaceutical Preparations / Q000008:administration & dosage* / Q000737:chemistry / Q000378:metabolism; D010599:Pharmacokinetics; D015990:Placebo Effect; D012107:Research Design; D012307:Risk Factors; D017211:Treatment Failure
chemical_list: D004364:Pharmaceutical Preparations