Methodologie et pratique du suivi a long terme des effets indesirables des medicaments chez l'enfant (cancers, leucemies, SID A, hormones de croissance)

摘要

Long term follow up for medicines used in children is necessary in some therapeutic areas. Long term effects (e.g. in cancer) may be detected many years after the treatment period. Growth, development and maturation specific to children can make these effects particulary harmful. The development plan of a paediatric drug should include, long term follow up on the basis of pharmacological-toxicologi-cal and safety data. These aspects should be taken into account when modifying the protocol (lower dosage, withdrawal of some associations etc). The follow up period may be very long, as in cancer (e.g. second tumour after treatment for cancer). A cohort is the best choice for this follow up, but other alternatives may be useful, including a specific follow-up Unit. Long term follow-up is nevertheless difficult and expensive, manpower-dependant and the risk of failure is great especially in the teenage years.