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On October 29, 2019, the University Medical Center Freiburg will open Germany's first interdisciplinary unit for early clinical trials in children / Lack of approval studies for drugs has made therapy difficult to date

Approval hurdles, lack of financial incentives, low patient numbers: There are many reasons why drugs are not approved for children. In order to close this gap and drive forward clinical trials in all pediatric specialties, a separate unit is now being set up at the Center for Pediatric and Adolescent Medicine at the University Medical Center Freiburg. In the so-called Children's Early Clinical Trials Unit (Children's ECTU), early pediatric clinical trials from the various specialist areas of pediatric medicine such as pediatric cardiology, neuropaediatrics, oncology, neonatology, gastroenterology and infectiology will be developed, supervised and evaluated in a separate unit for the first time in Germany. The special needs of young patients and their families are always kept in mind. An opening event for the Children's ECTU will take place on Tuesday, October 29, 2019 from 12.30 pm to 2.30 pm in the main lecture hall of the Center for Pediatric and Adolescent Medicine at Mathildenstraße 1 in Freiburg. Interested parties are cordially invited.

"Children are not small adults. Experiences from studies in adult patients cannot simply be transferred to children. With our new unit, we want to ensure that children and adolescents can also benefit from promising therapeutic approaches. We need to bring new drugs to young patients more quickly, because children and adolescents must not be left behind by progress," said PD Dr. Simone Hettmer, senior physician at the Center for Pediatric and Adolescent Medicine at the Freiburg University Medical Center.

Studies in children differ from those in adults on many levels: Young children cannot swallow tablets; the active ingredient must be administered as a juice. The degradation of the medication is different in young children than in adolescents; their metabolism in turn differs from that of adults. Special study regulations must also be observed for children, and time and space for discussions with the children and within the families must be planned as early as the study planning stage. In addition, many diseases in childhood, especially serious ones, are rare diseases. "Our new unit provides the infrastructure necessary to address the special needs of children and adolescents in early clinical trials and to enable our patients to participate in early clinical trials," continued Hettmer.

The guest speaker at the opening ceremony is Prof. Dr. Matthias Schwab, Director of the Dr. Margarete Fischer-Bosch Institute for Clinical Pharmacology in Stuttgart and member of the German National Academy of Sciences Leopoldina. Prof. Schwab researches why drugs have different effects on different people. Since 2018, he has headed the "German Network for Paediatric Trials" as part of the European "Conect 4 Children" initiative, which is committed to better consideration of children and adolescents in the development of new, innovative therapies. The Center for Pediatric and Adolescent Medicine at the University Medical Center Freiburg is a partner of "Conect 4 Children".

Contact: 
PD Dr. Simone Hettmer
Center for Pediatric and Adolescent Medicine
Freiburg University Medical Center
simone.hettmer@uniklinik-freiburg.de
Phone: 0761 270-45140