In this section you find political issues surrounding clinical trials with children.
In the US, legislation has gradually been introduced since 1997 which now provides financial incentives to companies to undertake clinical trials on products used in the treatment of children whilst the products are still “patent protected” (Better Pharmaceuticals for Children Act 2002). The Act also provides for research on older off-patent medicines through a priority list developed by the National Institutes of Health (NIH).
Although similar previous regulations have resulted in some success, there are a number of important children’s diseases where trials have not been conducted because of an insufficient financial incentive.
There are numerous examples of drugs often used in paediatric patients which have not been adequately studied in children, including: proton pump inhibitors which have limited indications for children but no suitable dosage form; phytomenadione for partial reversal of warfarin therapy; treatment or prophylaxis with low molecular weight heparin for thrombosis; antihypertensive medicines; clonidine for sedation in Paediatric Intensive Care Units (PICUs) and melatonin for sleep disturbance. For this reason, the US has introduced a legal obligation for companies to conduct trials with medicines for children where there is a therapeutic need, the Better Pharmaceuticals for Children Act 2002.
An European regulation, the Regulation of the European Parliament and of the Council on Medicinal Products for Paediatric Use, has been developed and accepted by the European Commission. This has established a system of requirements and incentives aimed at satisfying the need for medicines that are appropriately formulated and authorised for the treatment of children. This legislation has become law as per January 2007.