title: Pediatric clinical trial experience: government, child, parent and physician's perspective.
abstract: In contrast to investigations in adults, investigation of drugs via clinical trials has been lacking in the pediatric population. Until recently there was little incentive on the part of the pharmaceutical industry to conduct clinical trials of new drugs in children. However, government legislation approved in the late 1990s has promoted efforts to investigate the effects of drugs in the treatment of a variety of children's diseases. Such data provide important and needed information on appropriate dosing, rates and types of adverse reactions and efficacy for treatment of pediatric illnesses. The conduct of clinical trials in children is dependent on a careful dialogue between the investigator, child and guardians wherein a detailed description of benefits vs. risks is conveyed. The focus of this paper is to summarize various perspectives on conducting clinical trials in children, including those of the government, the child, the parents or guardians and the investigator. Although children now have access to new medicines during the development process, their participation in clinical trials must still protect them from undue risk and secure their well being.
authors.affiliation: Department of Pediatrics, University of Connecticut Medical School, Hartford, USA. jsalaza@ccmckids.org
authors.forename: Juan C
authors.initials: JC
authors.lastname: Salazar
mesh_terms: D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D017277:Drug Approval; D004341:Drug Evaluation; D004345:Drug Industry / Q000592:standards* / Q000639:trends; D015507:Drugs, Investigational; D005260:Female; D006801:Humans; D007223:Infant; D007258:Informed Consent; D008297:Male; D010290:Parents; D018579:Patient Selection; D010372:Pediatrics / Q000592:standards / Q000639:trends; D012107:Research Design; D014481:United States
chemical_list: D015507:Drugs, Investigational