Universitätsklinikum Erlangen starts research project
‘Pharmacotherapy in children is more difficult than in adults, as many drugs are used without sufficient testing and often information on efficacy, safety and dosage is missing,’ says Prof. Dr. Dr. h.c. Wolfgang Rascher, head of the Department of Paediatrics and Adolescent Medicine at Universitätsklinikum Erlangen. The European Union is providing six million euros in funding for a research project at the Erlangen university hospital to improve the safety of pharmacotherapy in children and adolescents.
The EU Paediatric Regulation, which came into effect in the beginning of 2007, obligates the pharmaceutical industry to present a plan for testing in children in case of new developments. ‘This has increased the number of clinical studies in children for newly developed drugs, but pharmaceuticals that have been on the market for a long time and for which there is no good data from controlled studies on efficacy and clinical safety remain problematic,’ says Prof. Rascher. Although these drugs are very effective and frequently prescribed, the pharma industry has little interest in control studies. Now the EU aims to remedy this by funding specific clinical studies in children and adolescents. In the most recent call for proposals on this subject, the European Union awarded the Erlangen Department of Paediatrics and Adolescent Medicine (PD Dr. Antje Neubert and Prof. Dr. Dr. h.c. Wolfgang Rascher) six million euros in funding for a research project.
The project’s consortium, consisting of altogether ten renowned institutions from all over Europe, aims to examine the use of the active agent clonidine, which is mostly known as an antihypertensive drug, for sedative use in paediatric intensive care. Clonidine is currently in use in paediatric intensive care without efficacy having been proven.
The consortium intends to use the results of the project ‘CloSed’ to achieve regulatory approval for children and adolescents and thus to contribute to a reduction in so-called ‘off-label use’ in children and adolescents.
Under the direction of PD Neubert, the Center for Clinical Studies (Head: Dr. Bernd Gebhardt) as well as the pharmacy (Head pharmacist: Dr. Frank Dörje, MBA) of Universitätsklinikum Erlangen will play a major role in the implementation of the project.
Information for the press
PD Dr. Antje Neubert
Phone: +49 (0)9131 85 33118