title: Design and conduct of early phase drug studies in children: challenges and opportunities.
abstract: It has historically been very difficult to conduct early phase drug studies in children for a number of reasons related to ethics, acceptability, rarity, standardization, end points, safety, dosing and feasibility. Over the past decade there have been a number of developments including novel clinical trial design, in silico pharmacology and microdosing that have significantly enhanced the ability of investigators to conduct early phase drug studies in children. While the evolution of drug therapy is creating a series of new challenges, there has never been a better time for conducting drug studies in children.
authors.affiliation: Department of Paediatrics, Robarts Research Institute, University of Western Ontario, Canada. mrieder@uwo.ca.|Department of Paediatrics, Western University, London, Ontario, Canada. mrieder@uwo.ca.
authors.forename: Michael
authors.initials: M
authors.lastname: Rieder
authors.affiliation: NIHR Alder Hey Clinical Research Facility, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.|Department of Women's and Children's Health, University of Liverpool, Liverpool, UK.
authors.forename: Daniel
authors.initials: D
authors.lastname: Hawcutt
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D055808:Drug Discovery / Q000379:methods*; D006801:Humans; D010372:Pediatrics / Q000379:methods*; D012107:Research Design / Q000639:trends*
keywords: children; clinical trials; drug development; early phase drug studies