topic Hightech Strategy

Clinical Trials

Clinical trials

Together with the German Research Association, the BMBF therefore launched a joint initiative for patient-oriented medical research in Germany in 2003. For the first time, clinical trials can now be funded irrespective of funding programmes limited to specific topics. The programme was introduced in 2005 and has an annual budget of 20 million Euro. BMBF funding thus enables the systematic development of clinical research in Germany. The BMBF provides funding for non-commercial clinical trials on pharmacological therapies as well as for systematic reviews of clinical trials in line with international standards. Funding is closely coordinated with the DFG, which provides funding for non-commercial clinical trials on non-pharmacological therapies as well as diagnosis studies, forecast studies and controlled studies for secondary prevention.

Clinical Study Centres

The aim of the "Clinical Study Centres" funding measure is to establish a sustainable infrastructure for coordinating patient-oriented clinical research (non-commercial, science-initiated clinical trials and possible cooperation with industry, e.g. in the framework of commercial clinical trials), to enhance methodological study competence and, above all, to provide participating hospitals with the resources needed to implement clinical trials. Important elements of a study centre include aspects of infrastructure and organization. This means, in particular, the establishment of study units in the participating hospitals, the establishment of a central unit for the management of clinical trials, measures for the initial and continuing vocational training of qualified staff for the implementation of clinical trials, as well as for the continuing training of physicians in the area of study concept development and coordination.

Study Network Surgery (CHIR-Net)

The vast majority of operative processes lack secured scientific findings which can be obtained by means of multi-centre clinical trials. The main reasons for this situation are considered to be a lack of research expertise and particularly high demands regarding methodology in surgical trials. The Study Network Surgery with five regional centres at the universities of Berlin, Mainz, TU Munich, Schleswig-Holstein and Witten-Herdecke/Cologne and with the Study Centre of the German Surgical Society (SDGC) in Heidelberg has received BMBF funding totalling 4.9 million Euro since 2005.

It pursues the aims of promoting the establishment of a nation-wide research infrastructure, supporting the continuing training of surgeons in the area of clinical trial research and implementing multi-centre, randomized clinical trials on surgical questions.
 
The "Paediatric Network for Drug Development and Testing in Children and Adolescents at KKS" (PAED-Net) was established in 2002. The majority of medical drugs which are regularly administered to children are not tested for this age group and are not approved for their use by the authorities (so-called off-label use). It is wide-spread practice to transfer results from adult surveys to children. However, this does not take into account the different metabolism of children at different stages in their development compared with adults. The BMBF will be providing 5.4 million Euro up until 2008. The PAED-Net institutions at the university hospitals in Freiburg, Heidelberg, Cologne, Leipzig, Mainz and Münster are conducting ethically sound and qualified drug trials with children, together with cooperation partners such as doctors in private practice and municipal hospitals.

Further information is available under http://www.gesundheitsforschung-bmbf.de/en/161.php