摘要: It is generally agreed that satisfactory safety and effectiveness of pharmaceutical products for children adolescents have not yet been established. This applies in particular to anti-cancer drugs even those having successfully used many years multidrug chemotherapy protocols childhood cancer. For example, nephroblastoma or Wilms’ tumor one the typical frequent forms cancer occurring at a median age about 3 years. Standard therapy combination vincristine actinomycin D; survival 85%. D, summary product characteristics states contraindication aged below 6–12 months. If this would be considered respected it mean substantial proportion with treated thus proven curative withheld. The current situation pediatrics off-label use has become common practice: private practice 20% prescriptions are off-label, children’s hospitals approximately 40%–50% 50%–70% pediatric oncology more than 90% neonatology (Conroy et al. 1999, 2000, 2003; Turner 1996, 1998; McIntyre 2000). These conditions less tolerated by authorities although they beyond legality. reason appropriate clinical trials like adults conducted therefore licensed.