Innovative clinical trial design for pediatric therapeutics.

Journal Article (Journal Article;Review)

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.

Full Text

Duke Authors

Cited Authors

  • Laughon, MM; Benjamin, DK; Capparelli, EV; Kearns, GL; Berezny, K; Paul, IM; Wade, K; Barrett, J; Smith, PB; Cohen-Wolkowiez, M

Published Date

  • September 2011

Published In

Volume / Issue

  • 4 / 5

Start / End Page

  • 643 - 652

PubMed ID

  • 21980319

Pubmed Central ID

  • PMC3184526

Electronic International Standard Serial Number (EISSN)

  • 1751-2441

Digital Object Identifier (DOI)

  • 10.1586/ecp.11.43


  • eng

Conference Location

  • England