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Failed Pediatric Drug Development Trials
Author(s) -
Momper JD,
Mulugeta Y,
Burckart GJ
Publication year - 2015
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.142
Subject(s) - drug development , medicine , clinical trial , intensive care medicine , adverse effect , drug , new product development , drug trial , pharmacology , business , marketing
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.