The Limits and Regulations of Paediatric Clinical Trials
Paediatric clinical trials are regulated by strict laws and ethical guidelines as society and adults are in a position to protect children. As regards clinical trials, children are an especially vulnerable group, which should be protected from unnecessary risks and stress. Clinical trials for this group are limited, and children must not be subjected to unnecessary risks. Moreover, the legal position of this particular group as minors must be taken into account. This means that the child is dependent on his or her guardian and unable to assess the significance and possible risks and stress of the clinical trials.
The most significant change in paediatric clinical trials was the EU's Regulation on Medicinal Products for Paediatric Use which came into force on January 26, 2007 and concerns all EU member states. In the future, suitable, studied and safe medicinal products will be available to children as the regulation puts the pharmaceutical industry under an obligation to conduct trials on all new medical products with the relevant study population, i.e. children and adolescents, if the EU medical authorities regard them as necessary. After July 2008, a new medicinal product will not be granted marketing authorisation in the EU if it has not been studied in the paediatric population. Medical authorities will make an exception and give marketing authorisation only if the illness which the product is intended to treat does not occur in children.