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Clinical trials for children

Many medicines administered to children have not been specifically developed for them. This means that no paediatric clinical trails were conducted to determine whether the drug is safe and effective in children.

Medicines authorized for adults are usually administered to children by decreasing dosages on the basis of weight, which is extremely hazardous. Children are not small adults and respond very differently to medicines at various ages and stages of their development.

This use, defined as off-label in children, is widespread and has been an increasing concern over the last years. Serious consequences, inefficacy and side effects often stem from incorrect dosage. In the European Union (EU), fifty per cent or more of medicines used in children have never actually been studied in this population, but only in adults, and not necessarily in the same indication (or the same disease).

The need for more studies to obtain paediatric information for medicines used in children is now a matter of consensus on a global basis. This section provides information on the necessity for clinical trials with children, and what ethical and political aspects are involved. It also provides links to other websites you can visit to look for answers to your questions if you or your child is getting involved in a clinical study.