[Methodology and long-term follow-up of drug induced side effects in children (cancer, leukemia, AIDS, growth hormone)].
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 particularly harmful. The development plan of a paediatric drug should include, long term follow up on the basis of pharmacological-toxicological 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-dependent and the risk of failure is great especially in the teenage years.
Hoog-Labouret
N
N
Agence Française de Sécurité Sanitaire des Produits de Santé, Saint-Denis, France.
Lassale
C
C
Eschwege
E
E
D000163:Acquired Immunodeficiency Syndrome / Q000453:epidemiology; D000293:Adolescent; D019380:Anti-HIV Agents / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D007938:Leukemia / Q000139:chemically induced* / Q000453:epidemiology*; D008297:Male; D009369:Neoplasms / Q000139:chemically induced* / Q000453:epidemiology*; D012107:Research Design; D016019:Survival Analysis
D019380:Anti-HIV Agents