Healthy Skepticism Library item: 8048

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Publication type: Journal Article

Bush A.
Clinical trials research in pediatrics: strategies for effective collaboration between investigator sites and the pharmaceutical industry.
Paediatr Drugs 2006; 8:(5):271-7

Abstract:

There is a paucity of clinical trials work in children, which leads to the frequent use of off-label and unlicensed medications in this very vulnerable group. Clinical trials work in children may be more difficult than in adults, and there are certainly ethical constraints. However, the differences between adults and children, and at different stages of childhood development, mandate strategies to improve this situation rather than continually relying on extrapolation from adult studies. Therefore, new strategies have to be established between the pharmaceutical industry and pediatric centers to facilitate effective trials work. These must be based on a clear and mutual understanding of the differences between working with children and adults. Disease phenotypes may be completely different in children; for example, wheeze in infants is not miniature adult asthma. Clinical trial design must be practical, and a trial is more likely to succeed if a simple design is utilized, with minimal interference with school work and the work of carers. The new UK initiative, ‘Medicines for Children’, should go a long way towards addressing the problem, and increase the evidence base for the utilization of medications in pediatric practice.

Keywords:
MeSH Terms: Biomedical Research* Child Child, Preschool Clinical Trials*/methods Clinical Trials*/standards Cooperative Behavior* Drug Industry* Humans Infant Infant, Newborn Pediatrics* Pharmaceutical Preparations/administration & dosage Pharmaceutical Preparations/adverse effects Research Design Substances: Pharmaceutical Preparations