Urszula Kurczewska, Beata Welk-Piela, Daria Orszulak-Michalak

Badania kliniczne z udzialem dzieci

Paediatric clinical trials.According to European Medicines Agency over 50% of paediatric drugs was never examined with clinical trials and are not authorized for use in children. Clinical trials are costly and difficult to conduct because of heterogeneity of population. They provoke also a lot of ethical concerns. The paper presents the problem of paediatric clinical trials. A special attention was put on Regulation No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use.