Children are not small adults: they often react differently to drug products than grown-ups. Their organs such as the liver and kidneys are not fully developed. But very few drug products have been tested in the 0 to 17 years age group: clinical trials with underage patients are a controversial subject. To help sick children and adolescents, pediatricians often have no alternative than to prescribe medicines for their small patients that have only been tested and approved for the treatment of adults.
New EU-wide regulation
A regulation that has been in force throughout Europe since 2006 is intended to change that: all new or extended medication approvals now also require clinical studies on children of all ages in order to ensure the efficacy, safety and tolerability of the drug product for use in pediatrics. Bayer HealthCare has likewise reacted: a workgroup is supporting the development of pediatric trial concepts.