title: Clinical trials in children--How are they implemented?
abstract: Drug metabolism in children may differ from adults and adverse events may occur that are not predictable from the adult experience. Clinical trials of safety and efficacy are needed both for new treatments and those that may already be in use but have not been tested in infants and children. The role and responsibilities of different participants in a trial are discussed, including the steering committee, the clinical and statistical co-ordinating centers, and the data and safety monitoring board. Advantages of external vs internal pilot studies are reviewed. Information that is available on the websites of the Food and Drug Administration and the National Institute of Neurological Disorders and Stroke may be helpful to those planning clinical trials of interventions in children.
authors.affiliation: National Institute of Neurological Disorders and Stroke/National Institutes of Health, Bethesda, Maryland 20892, USA. hirtzd@ninds.nih.gov
authors.forename: Deborah G
authors.initials: DG
authors.lastname: Hirtz
authors.forename: Peter R
authors.initials: PR
authors.lastname: Gilbert
authors.forename: Cindy M
authors.initials: CM
authors.lastname: Terrill
authors.forename: ShaAvhree Y
authors.initials: SY
authors.lastname: Buckman
mesh_terms: D000328:Adult; D002648:Child; D026661:Clinical Trials Data Monitoring Committees; D002986:Clinical Trials as Topic; D006801:Humans; D010865:Pilot Projects; D012107:Research Design; D020521:Stroke / Q000188:drug therapy*; D014481:United States; D014486:United States Food and Drug Administration