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Clin Pharmacol Ther. 2015 Sep;98(3):245-51. doi: 10.1002/cpt.142. Epub 2015 Jun 26.

Failed Pediatric Drug Development Trials.

Author information

1
Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, La Jolla, California, USA.
2
Pediatric Clinical Pharmacology Staff, Office of Clinical Pharmacology, Office of Translational Sciences, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

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.

PMID:
25963725
DOI:
10.1002/cpt.142
[Indexed for MEDLINE]

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