Future Organization of Clinical Research in Germany: The Road to the „German Centre for Digestive Health“ (GCDH)

Unmet needs have to be defined

Despite of all the freedom necessary for independent research “unmet needs” in clinical research have to be defined based on problems arising from everyday patient care. Politics in general and research politics in particular have to decide how much tax payer money should or can be allocated to overall research and to biomedical research in particular which also means investment in the future of the society. Demographic changes all over Europe force governments as well as the whole society to change strategies. However, the definition of specific topics to be tackled by national and international research programmes must be defined by the scientific community. The German Ministry of Research and Education (BMBF) has continuously reached out to the scientific community including scientists in clinical medicine. Approximately one decade ago the road map concept was designed by the BMBF ministry in close collaboration with basic and clinical scientists. Research funding is not only based on tax payers’ money but also on private investment and donations including support by private foundations and the pharmaceutical industry. In Germany universities are run and financed by the individual 16 states of the federal republic. In addition the Federal Government (Bundesregierung) supports academic research in various ways. One major source of university research funding is through the German Research Foundation (Deutsche Forschungsgemeinschaft – DFG). The German Research Foundation is an association where all the individual universities are individual members. This is described in German as “Vereinsmodell”. Further federal government research funding is mediated through specifically defined programmes of the Federal Ministry for Research and Education (BMBF). BMBF funded programs are usually designed for a limited time period. The Federal Government also finances non-university research institutes which on average are partially financed by the specific states where they are located. There are several non-university research organizations with individual research institutes all over Germany. These include institutes of the Max-Planck Society, the Leibniz Society, the Association of Fraunhofer Institutes and the Helmholtz Association of Research Institutes with its five institutes focused on biomedical research (www.helmholtz.de). The five Helmholtz Institutes for biomedical research are also playing a central role within the German Centres of Health Research (Deutsche Zentren der Gesundheitsforschung (DZGs)). These DZGs established an important national network between university and non-university translational and clinical research institutions.

Collaborations between university and non-university research institutions need to be explored and further developed in order to successfully tackle the biggest unmet needs in clinical research. For their translational research programmes non-university research institutions more than ever need access to patient cohorts and thus patient care. This is not possible without a close collaboration with academic medicine. In Germany academic hospitals are run by the university itself which differs from many other countries like England, USA and Australia. University hospitals have to strengthen and further develop their infrastructure for patient-oriented research. In addition to further develop and strengthen the institutional infrastructure paths for individual careers and chances have to be further developed that allow physicians with a research interest to develop a career in academia as a clinical scientist after completion of research as well as clinical training.

The establishment of various German Centres for Health Research (DZGs) has highlighted several major health burdens and threats to the society. Significant resources were allocated to these DZGs. DZGs were so far established for translational research in cancer, heart, lung and neurodegenerative diseases, infectious diseases as well as diabetes (www.bmbf.de/de/deutsche-zentren-der-gesundheitsforschung-394.html). In addition significant attention and funding has been allocated to the research in rare diseases: “Care for rare”. Years before DZGs where established and funded by BMBF “networks of competence” in medicine as well as integrated research and treatment centres (IFBs) where established and also funded with hundreds of millions of Euros (www.kompetenznetze-medizin.de; www.ifb-portal.de). All these major efforts by the BMBF aim at improving translational and clinical research in Germany. The field of gastroenterology and hepatology was quite successful in the programme of “networks of competence” in medicine through the establishment of the network of competence on viral hepatitis (HepNet) (www.kompetenznetz-hepatitis.de; www.deutsche-leberstiftung.de) and inflammatory bowel diseases (Kompetenznetz CED (www.kompetenznetz-ced.de)). However, gastroenterology and hepatology so far have been unsuccessful in acquiring resources to establish a specific DZG or IFB. Some members of our scientific community are involved in the German Centre of Infection Research (DZIF) (www.dzif.de). The field of gastroenterology and hepatology which is best described by “digestive health” covers a huge spectrum of acute and chronic diseases which are threats not only to the individual patient but also a major burden to the society and ideally coped with what the German language calls “Volkskrankheiten”. United European Gastroenterology (UEG (www.ueg.eu)) which is the umbrella of national societies of gastroenterology and hepatology, altogether 46 and the European scientific societies of all its subdisciplines (altogether 16) has published a white book (https://ueg.eu/epaper/WhiteBook.Brochure/index.html) under the title of “digestive health”. The term “digestive health” summarizes ideally much better what is covered by all the different aspects of our discipline than any German word could do. These diseases include chronic inflammatory gastrointestinal diseases like inflammatory bowel disease (IBD) and gastritis, acute and chronic pancreatitis, acute and chronic liver diseases including alcohol-induced liver disease, fatty liver disease (metabolic), viral hepatitis A – E, chronic cholestatic liver diseases, gastrointestinal, pancreatitis and liver cancer as well as nutrition medicine. This also includes disciplines in pediatrics as well as internal medicine and also the various disciplines of visceral and abdominal surgery.