Photo: Middle: Prof. Matthias Schwab, from left to right: Dr. Gabriele Ahne, Roswitha Zuehlsdorff, Dr. Svitlana Igel, Ute Leicht, Vera Bührer.
What is the GermanNetPaeT? It is the German Network for Paediatric Trials and was founded in 2018 as the German National Hub (NH), a partner of the European conect4children network (c4c network). GermanNetPaeT is highly motivated to pursue the goal of c4c, i.e. to ensure that better medicines for babies, children and young people will be available through the conduct of high quality clinical trials.
Our lead is Prof. Matthias Schwab, paediatrician and clinical pharmacologist, who is Professor at the Eberhard Karls University Tuebingen, Germany. M. Schwab heads the Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology, Bosch Health Campus, Stuttgart, Germany and the Department of Clinical Pharmacology, University Hospital Tuebingen, Germany. Together with the coordinating team at the NH comprising of Dr. Gabriele Ahne (Project Management), Roswitha Zuehlsdorff (Process Coordination & Quality Assurance), Dr. Svitlana Igel (Clinical Trials), Ute Leicht (Controlling & Contracting) and Vera Bührer (Secretary), a powerful and highly engaged working group has been established.
Within the last 4 years, the GermanNetPaeT has grown into a well-connected national network including 28 high quality clinical trial sites, which covers in addition to paediatric study centers, child and adolescent psychiatric study sites. These centres guarantee access to a representative pool of potential paediatric patients contributing to clinical trial activities and to fulfil the goals of c4c. The GermanNetPaeT contributes to c4c non-industry proof of viability trial (PoV) KD-CAAP (Kawasaki-Disease) and an industry PoV trial FIONA (chronic kidney disease) and participated to several feasibility studies.
To facilitate high quality clinical trials in Germany, we provide early site identification and feasibility processes for sponsors and trial sites. For educational aspects, we support a wide range of training activities of the c4c-Academy for network members. In cooperation with KKSN (Network of Coordination Centers for Clinical Studies), the NH initiated a cost calculation working group focusing on paediatric specific aspects and their relevance for trial costs.
Moreover, on the European level, the GermanNetPaeT and its third parties provide specific expertise for example: “Pharmacogenomics and other OMICs Technologies” (Prof. M. Schwab, lead of the expert group), “Endocrinology and Diabetes in children” (Prof. T. Danne), ethical issues with specific focus on paediatric clinical trials (Prof. D. Lanzerath), paediatric pharmacovigilance (Prof. A. Neubert) and c4c educational activities as well as data quality standards issues.
The ultimate vision of GermanNetPaeT is to further maintain and exploit efficient, high quality and sustainable national activities regarding paediatric clinical trials and to act as single point of contact (SPoC) within the European c4c network.
For more information please click here: GermanNetPaeT