Clinical trials in children: problems and pitfalls.

Recent initiatives by the US Congress and the Food and Drug Administration have provided effective incentives to develop new drugs for children leading to a dramatic increase in the number of paediatric clinical trials being done in the US. There also is increased international interest in development of pharmaceuticals for children as reflected in the draft International Conference on Harmonisation guidelines. The demands created by these initiatives are challenging the industry, regulators, and clinical investigator community. As the infrastructure for paediatric clinical research evolves, it is paramount that the ethical issues unique to children are not forgotten and that children do not become a commodity in the clinical trial economy. Furthermore, it is important to recognise that the adult paradigm for clinical research cannot simply be imposed on paediatric studies and that protocols must be appropriately designed for different age groups. Clinical studies can be, are being, and will continue to be successfully carried out in children on behalf of children so that ultimately children can benefit from therapeutic advances to the same extent enjoyed by their parents and grandparents.