Patient-oriented clinical Research

There can be no new medical drug, no innovative therapy without clinical trials. New processes and medical drugs are tested in clinical trials. They are part and parcel of quality assurance in medicine. But they also provide insights into the origins and progress of diseases. Therefore the Federal Ministry of Education and Research provides funding for clinical trials on pharmacological therapies as well as for systematic reviews. Additionally funding is provided for the establishment of essential infrastructure for the coordination and implementation of 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.

Coordination Centres for Clinical Trials (KKS)
The BMBF has been funding the establishment of Coordination Centres for Clinical Trials (KKS) since 1998. The KKS are to support all processes of clinical trials and develop the quality of patient-oriented clinical research at universities. This includes trials initiated by science as well as clinical trials initiated by industry. A KKS is a central service institution of a higher education institution. The higher education institution provides personnel and logistic resources and competences to plan, prepare, implement and evaluate clinical trials. Due to their location at university hospitals and overarching networking, the KKS are also interesting partners for the pharmaceutical industry and medical technology in implementing multi-centre trials.

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 (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 and 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.

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.

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.

German Clinical Trial Register
Clinical Trials are a valuable instrument to improve health care. Often relevant results of trials remain unpublished. The German Clincial Trial Register will help to assure that
- no participant within a trial take on a potential personal risk, without contributing to scientific knowledge
- publication bias due to omitted publication will be avoided
- unnecessary repetition of similar trials will be avoided
- important information concerning the status quo in science will be accessible to patients, medical doctors, scientists, industry and public organisations.

The German Clinical Trial Register will participate in the international initiative “International Clinical Trial Registry Platform” coordinated by the WHO. Information of each registered trial will be available in English and German. All kinds of trial (e. g. drugs, medicinal products or psychotherapy) shall be registered. Establishment of the German Clinical Trial Register will be in close cooperation with the German ethics committees.



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