Children have equal rights – also in the case of medical care. This was not always ensured. Only in January 2007, the Pediatric Regulation came into force. This regulation obliges pharmaceutical companies to investigate new drugs also in the paediatric population when the condition for which the drug shall be used occurs in childhood and adolescence.
So far, many children still receive drugs that have only been tested in adults and are therefore not specifically approved for paediatric patients (so called off-label treatment). Experience and results from clinical trials in adults do not allow conclusions about the efficacy and safety for children. Hence, age-appropriate forms of dosage (e.g. juice, drops) are missing just like there is no product liability of the manufacturer. Additionally, the use of drugs not adequately tested in children increases the risk for adverse drug reactions (side effects). With your help, we want to ensure that children are offered the same safety in medication and therapy as adults.
The Paediatric Clinical Study Centre in the Department of Paediatrics and Adolescent Medicine
All employees at the Department of Paediatrics and Adolescent Medicine are dedicated to ensure optimal treatment for your child. At the same time, they would like to develop safe medical products for all children. The conduct of clinical trials is complex because it is all about the best possible treatment and the safety of your child. A clinical trial is implemented according to strict legal requirements. In order to fulfill these requirements and to be able to dedicate full attention to your child at the same time, the Paediatric Clinical Study Centre was established at our hospital. All our medical and scientific staff have extensive experience in the medical care of children and are certified study investigators with knowledge on the legal framework for the conduct of clinical trials. Our study assistants are registered paediatric nurses who have completed additional study nurse training. Through regular advanced training courses, all our employees ensure that their expertise and skills are constantly up to date.
If you are being proposed the participation of your child in a clinical trial, you can be sure that in the framework of the trial your child will be treated and monitored to the best extent possible. With your participation in a clinical study, you can additionally help other children with the same medical condition. The participation in a clinical trial is completely voluntary. The only requirement is a detailed informative interview with your treating physician as well as the consent of both parents and assent from the child. As legal guardian you can refuse the consent to participate to a clinical trial at any time and without any disadvantages in the treatment of your child. Please help to ensure that children can be treated in a safer way. For further questions please do not hesitate to contact us.
Tel: +49 9131 85-41203