Why are clinical studies in children necessary?
Not only affected parents often ask themselves why drug studies in children are necessary, in particular when extensive trials on adults have already been conducted. It is easy to explain why such studies are indispensable: an adult’s body and organism is very different from that of a child, which is why medicinal products may have different effects as well. To verify the doses required to treat children, in order to achieve the best possible effect and avoid potential side effects, medicinal products must be tested specifically on children. In the absence of such information, medicinal products may be ineffective, or even unsafe, in children.
A major part of the drugs currently administered to children has never been adjusted to their needs. Although most of these medicinal products have already been approved, pharmaceutical companies are now required by new European laws to test new medicinal products specifically on children and to have them approved for children.
A lack of studies is a common problem especially when it comes to newborns: more than 90% of all medicinal products used in neonatal intensive care units have never been tested on the special patient group of premature and sick newborn infants. Clinical studies in infants are a great opportunity to increase the safety and effectiveness of existing treatment options.
Not only the children who are treated in the context of such studies but also future patients will benefit from their participation in a clinical study. During the entire study, the participants are given excellent and comprehensive care and advice:
- Extended range of examinations, including extensive medical advice and care in specially trained multiprofessional study teams.
- Treatment with a medicinal product that complies with the latest medical findings
- New treatment options for rare childhood diseases where only a few or no satisfactory treatment options used to be available.