Innovative clinical trial design for pediatric therapeutics

Matthew M. Laughon, Daniel K. Benjamin, Edmund V. Capparelli, Gregory L. Kearns, Katherine Berezny, Ian Paul, Kelly Wade, Jeff Barrett, Phillip Brian Smith, Michael Cohen-Wolkowiez

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73 Scopus citations

Abstract

Until approximately 15 years ago, sponsors rarely included children in the development of therapeutics. US and European legislation has resulted in an increase in the number of pediatric trials and specific label changes and dosing recommendations, although infants remain an understudied group. The lack of clinical trials in children is partly due to specific challenges in conducting trials in this patient population. Therapeutics in special populations, including premature infants, obese children and children receiving extracorporeal life support, are even less studied. National research networks in Europe and the USA are beginning to address some of the gaps in pediatric therapeutics using novel clinical trial designs. Recent innovations in pediatric clinical trial design, including sparse and scavenged sampling, population pharmacokinetic analyses and 'opportunistic' studies, have addressed some of the historical challenges associated with clinical trials in children.

Original languageEnglish (US)
Pages (from-to)643-652
Number of pages10
JournalExpert Review of Clinical Pharmacology
Volume4
Issue number5
DOIs
StatePublished - Sep 1 2011

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All Science Journal Classification (ASJC) codes

  • Pharmacology, Toxicology and Pharmaceutics(all)
  • Pharmacology (medical)

Cite this

Laughon, M. M., Benjamin, D. K., Capparelli, E. V., Kearns, G. L., Berezny, K., Paul, I., Wade, K., Barrett, J., Smith, P. B., & Cohen-Wolkowiez, M. (2011). Innovative clinical trial design for pediatric therapeutics. Expert Review of Clinical Pharmacology, 4(5), 643-652. https://doi.org/10.1586/ecp.11.43