REGULATORNI ASPEKTI I KLINIČKA ISTRAŽIVANJA U PEDIJATRIJI.

Through history major changes in drug regulation came after disasters when certain drugs caused fatal outcomes or disabilities (e.g. thalidomide disaster). Pediatric Regulation came into force in European Union in January 2007. The regulation objectives are to facilitate development of paediatric medicines through high quality clinical research and to increase the number drugs with proven efficacy and safety in children while reducing "off-label" use. According to new regulation, a Pediatric Investigation Plan has to be agreed for new drugs that would be registered in the EU. A waiver is granted for cases of conditions or diseases unlikely in pediatric population and a deferral when further data on safety or efficacy from adult population are needed. During clinical research children should not be exposed to unnecessary clinical trials and smallest possible number of children should be enrolled but with keeping statistical strength of the study. Therefore efficacy from adults can be extrapolated if indication, disease process and outcomes are the same in adults and children; in such situations studies of pharmacokinetics and safety should be performed in children. Since 2007 the number of clinical trials and children enrolled is increasing and so is the number of drugs registered for children. [ABSTRACT FROM AUTHOR]