title: Innovative clinical trial design  for pediatric therapeutics.
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.
authors: School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
authors: Matthew M
authors: MM
authors: Laughon
authors: Daniel K
authors: DK
authors: Benjamin
authors: Edmund V
authors: EV
authors: Capparelli
authors: Gregory L
authors: GL
authors: Kearns
authors: Katherine
authors: K
authors: Berezny
authors: Ian M
authors: IM
authors: Paul
authors: Kelly
authors: K
authors: Wade
authors: Jeff
authors: J
authors: Barrett
authors: Phillip Brian
authors: PB
authors: Smith
authors: Michael
authors: M
authors: Cohen-Wolkowiez
mesh_terms: D000367:Age Factors; D002648:Child; D002986:Clinical Trials as Topic / Q000379:methods* / Q000639:trends*; D006801:Humans; D010372:Pediatrics / Q000379:methods / Q000639:trends*; D004364:Pharmaceutical Preparations / Q000008:administration & dosage; D035703:Therapies, Investigational / Q000379:methods* / Q000639:trends*
chemical_list: D004364:Pharmaceutical Preparations