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Background: The German National Surgical Trial Network (CHIR-Net) which has been funded since 2006 by the Federal Ministry of Education and Research (BMBF, funding code 01GH1001A-01GH1001F, 01GH0702) is made up of eight regional surgical centers. The aim of the CHIR-Net is the design, implementation and publication of prospective, randomized, multicenter trials to support evidence-based medicine in surgery. Two main pillars of the CHIR-Net are the surgeon on rotation program and the flying study nurse program. With these two programs the surgical hospitals are supported in their trial working by educating competent investigators and the infrastructural support of flexible and mobile study nurses., Methods: The surgeon on rotation program and the concept of the flying study nurse are presented descriptively. Furthermore, this paper provides reports of experiences of a surgeon on rotation and a flying study nurse of the CHIR-Net. Additionally, the results of an on-line evaluation of the regional surgical hospitals (belonging to the regional surgical center of the universities Witten/Herdecke and Cologne) regarding the needs and requirements of the regional surgical hospitals are presented., Results: The surgeon on rotation program of the CHIR-Net offers investigators the possibility to acquire the basics of designing, developing and implementation of high quality clinical trials. In addition, their own study projects could be intensively driven forward. The flying study nurse program enables in particular non-university surgical hospitals to be supported competitively in performing their own study projects and participating in muliticenter clinical trials. The success of these two programs has been confirmed by the conducted evaluations and the presented field reports., Conclusion: The CHIR-Net is able to develop a high quality study culture in Germany with its surgeon on rotation and flying study nurse program. In addition to the funding period by the BMBF, the continuance of the CHIR-Net should be a primary aim of further measures.

Medicine is based on a pluralism of different ways of thinking and practical approaches. Given this assumption, the history and experiences of the 2 German governmental research funding programs 'Unconventional Methods of Cancer' (UMK) and 'Unconventional Medicine Directions' (UMR) are described from the perspective of the project supporter of 2 working groups that were based at the University of Witten/Herdecke, Germany, on behalf of the federal government. The results of a nationwide inventory analysis conducted under my direction in the years 1989–1992 showed a distinct lack of human and infrastructural resources for competitive research for complementary medicine at that time. The field of complementary medicine was found to be very heterogeneous and was divided into procedures without any visible research interest, but also contained approaches nourishing mainstream medicine by its different paradigm. The representatives of complementary medicine were and still are recognizably interested in evaluative, empirical research. The following contains our funding recommendations made for the relevant ministries, the advertised funding issues, and the research activities carried out. Although this governmental research funding was limited, a signal function can be awarded, retrospectively. For the subsequent period, there has been a significant improvement in infrastructural, staff, and research conditions. This development led to a significant increase in the level of quality and the acceptability of research results. As a result of an increased willingness for cooperations, the foundations, concerns, and activities of the 'dialogue forum pluralism in medicine' set up in 2000 are presented and compared with the situation at the time of research funding by government. 'Integrative Medicine' is currently being favored and welcomed as a sign of better mutual acceptance. Nevertheless, complementary medicine is still seen as being creative, enriching medical and health care, improving the patient-centeredness, and thus as an educational (unrest) element (of agitation)., (Copyright © 2013 S. Karger AG, Basel.)

Background: With the amendment to the German Drug Law in 2004, the conduct of clinical trials changed by at least two main aspects: (1) The principles of Good Clinical Practice (GCP) were implemented in the national legislation, and (2) for the first time, the function of the sponsor of a clinical trial and the clinical trial itself have become legally binding definitions. By that, legal differences between industrial and academic clinical trials no longer exist. Clinical trials initiated by investigators have to fulfil the same requirements while the entire sponsor responsibility has to be carried out by the Coordinating Investigator or his institution including implementation of a quality management system according to the GCP., Purpose: The Cologne Sponsor Model is an effective approach with settings, structures, basic features, action, and reporting lines, as well as funding for clinical trials initiated in an academic environment., Results: The University of Cologne assumes the sponsor responsibility for clinical trials organised by the university researchers according to law. Sponsor's duties are delegated to a central operational unit of the sponsor - the Clinical Trials Center Cologne - which further delegates duties to the Coordinating Investigator. Clinical Trials Center Cologne was established in 2002 to support the performance of clinical trials at the university by offering comprehensive advisory and practical services covering all aspects of study planning and conduct. Furthermore, a specialised division of its quality management department acts as an independent sponsor's Quality Assurance Unit. The Clinical Trials Center Cologne has established a quality management system consisting of different components (1) to enable a reasoned decision to subsequent delegation, (2) for risk-based surveillance of trial conduct (audits, monitoring-checks, and reports), and (3) support and training of the Coordinating Investigator., Limitations: Double functions of persons and departments in the university environment sometimes make it difficult to define roles in such a model. Therefore, it is necessary to establish clear reporting lines and moreover to monitor regularly and carefully the roles and responsibilities., Conclusions: With the combination of central management and support, control and independence of the researchers, our model represents a 'risk-based' system that offers a sensible option that fulfils the requirements of legal regulations and GCP for trials organised within the university environment.

In Germany, health services research has become an important area of research. Health services research is a multidisciplinary field of scientific investigation that studies central problems of health care to increase knowledge and understanding and provide solutions for those problems. The paper aims to demonstrate the value of health services research for health care practitioners by defining its central tasks, by describing the development of this research field in Germany and by deriving future challenges for health services researchers.

Health insurance funds need the results of health services research more than ever due to the socio-legal and socio-economic conditions currently prevailing. This should be possible by taking transparency and data protection into consideration, by cooperating with outside researchers while ensuring flexible use of routine data and if necessary gathering additional data, and by establishing links to epidemiological and registry data. It should become normative to clear the way for health insurance funds to regularly include this type of research in budget planning and to this end provide access to a suitable source of funds. In conclusion, it can simply be stated that it no longer suffices to effectively make a new clinically tested procedure, product, and service available because health insurance funds and their partners must know more precisely what this all accomplishes in practice.

Introduction: Transplantation medicine offers multiple translational questions which should preferably be transferred to clinical evidence. The current gold standard for testing such questions and hypotheses is by prospective randomized controlled trials (RCT). The trials should be performed independently from the medical industry to avoid conflicts of interests and to guarantee a strict scientific approach. A good model is an investigator initiated trial (IIT) in which academic institutions function as the sponsor and in which normally a scientific idea stands before marketing interests of a certain medical product., Methods: We present a model for an IIT which is sponsored and coordinated by Regensburg University Hospital at 45 sites in 13 nations (SiLVER study), highlight special pitfalls of this study and offer alternatives to this approach., Results: Finances: financial support in clinical trials can be obtained from the medical industry. Alternatively in Germany the Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung) offers annual grants. The expansion of financial support through foundations is desirable. Infrastructure: sponsorship within the pharmaceutics act (Arzneimittelgesetz) demands excellent infrastructural conditions and a professional team to accomplish clinical, logistic, regulatory, legal and ethical challenges in a RCT. If a large trial has sufficient financial support certain tasks can be outsourced and delegated to contract research organizations, coordinating centers for clinical trials or partners in the medical industry., Conclusions: Clinical scientific advances to improve evidence are an enormous challenge when performed as an IIT. However, academic sponsors can perform (international) IITs when certain rules are followed and should be defined as the gold standard when scientific findings have to be established clinically.

Translation of basic research results into routine patient care is delayed in parts by lack of institutionalization in clinical research. In this article the research structure and organization of our Department of Cardiac, Thoracic, Transplantation and Vascular Surgery are described.Basic research, separately directed, is accomplished in the Leibniz Research Laboratories for Biotechnology and Artificial Organs (LEBAO) and within the scope of the Excellence cluster "REBIRTH--from Regenerative Biology to Reconstructive Therapy".Clinical research is directed by heads of the subdepartments of our institution (valve and coronary surgery, aortic surgery, surgical electrophysiology, vascular surgery, thoracic surgery, cardiac assist systems, thoracic transplantation, intensive care and pediatric heart surgery).A separate subdepartment for clinical research is responsible for study coordination and accompanies clinical studies from study design and patient screening to publication. This subdepartment also serves as a constant contact to sponsors and superordinated research organizations within the Hannover Medical School.

Surgical research in Germany occupies a lower position in international ranking than expected. According to the size of the population, the economic impact, the gross domestic product and the research funding capacity, the impact of German surgical research should be much higher. Reasons are a more intensive commitment to patient care, structural differences and a changing lifestyle in younger doctors in comparison to many leading countries. If the situation is to be improved all factors have to be evaluated and, if possible, changed. Overall, German surgeons are underrepresented as readers and authors in the scientific market, which is mostly in the English language.

As a result of the demographic development of industrial nations the number of musculoskeletal diseases and injuries rises continuously. This challenges health care as well as clinical research and demands additional endeavours. The United Nations have recognised this issue at an early stage. With their in 2000 declared Bone and Joint Decade they have significantly contributed to a sustainable support of research activities. The German government has also perceived the need and, with their roadmap programme, encourages research of musculoskeletal disease.Today, surgical and orthopaedic clinics increasingly support the exchange between research and clinic and run their own research departments. The Berlin Center for Musculoskeletal Surgery (CMSC) and its research institute Julius Wolff Institut show the potential for surgical research. It shows that based on a clinical understanding of the problem, basic research needs to be complemented in a network with partners from other disciplines. However, interdisciplinary cooperation demands new and individual ways of communication and education. The example in Berlin also illustrates that the research on prevention not only completes the network but more over opens unexpected possibilities in understanding basic research and translation.

Clinical trials play a key role in patient care, academic education and research in surgery. Without valid studies the practice of evidence-based medicine is limited. Surgery is supported through funding by the German Ministry of Education and Research to establish an infrastructure for clinical trials. So far seven universities have worked together in a network since 2007 and successfully obtained funding for six large randomized trials from a program existing since 2004. Until now 2,249 patients have been randomized within 11 trials and 910 patients have been treated at local hospitals without academic responsibilities. An increase in the interest in clinical trials in daily practice has resulted through the certification of hospitals for special treatment that specifies that at least 5% of all patients are included in clinical trials.

In the late 1990s a funding program was set up by the federal German government to help keep stride with developments in the international research arena. Within this programme, Coordinating Centres for Clinical Trials ("Koordinierungszentren für Klinische Studien", KKS) were established at 12 German universities aiming at supporting all processes of academic clinical trials according to international standards. A close network infrastructure was chosen in order to reap maximum benefit from synergy effects and to promote the harmonisation of standards. Continuing to grow, the KKS Network currently has 16 research institutions as members. More than 400 employees within the KKS Network provide scientific services to clinical trials at universities, hospitals and in industry. In cooperation with study clinics, surgeries, study groups and competence networks in medicine within Europe and beyond, the KKS supports many different research projects covering all areas of medicine. The KKS Network contributes expertise to legislative processes within Germany and Europe through its work in professional committees and working groups. A wide range of education and training concepts supports clinical research as a scientific field in its own right. After nearly ten years the KKS Network has established itself as an indispensable partner in the field of clinical research.

In order to provide a central portal for information on clinical research in Germany and thus to facilitate the search of planned, ongoing and completed clinical trials, the German Clinical Trials Register (GermanCTR) was implemented in cooperation with the WHO's registries network. It is an open access online register of clinical trials conducted in Germany, which allows all users to search for, register and share information on clinical trials. The project is funded by the Federal Ministry of Education and Research and is implemented at the Institute for Medical Biometry and Medical Informatics of the University Medical Center Freiburg as a joint project of the Clinical Trials Center Freiburg and the German Cochrane Center. Since October 2008 the GermanCTR is an approved WHO Primary Registry and allows clinical trial registration in Germany according to the requirements of the International Committee of Medical Journal Editors (ICMJE). Reasons for a national trials register, general and technical aspects of implementing the GermanCTR as well as the national and international integration are described here.

The article reports on a funding programme jointly initiated in 2000 by Germany's Federal Ministry of Education and Research and its statutory health insurance funds ("Health Services Research in the German Health Care System"). In the past 5 1/2 years about 30 heterogeneous projects were funded with overall less than 6 million euros. Though in some projects obstacles to the research process have already become evident, it seems too early to evaluate their scientific merit. If health services research under the auspices of Germany's social insurance schemes is to develop further more funds must be invested and additional institutions (e.g. pension funds) included.

The 108th German Medical Assembly adopted a 6-year support initiative for health care research in order to contribute to the further development of this young scientific discipline which has not yet been sufficiently established in Germany. The program is focussed on the following subjects: (1) influence of economic changes on outpatient and inpatient medical care, (2) implementation of medical guidelines in medical routine and (3) the physician factor. Setting methodical standards in this new field and opening up access to medical data should provide a relevant impulse to health care research in Germany. The promoting strategy of the German Medical Association will be completed by initiating a network of scientists, research promoters and health care players.

Background: Research in General Practice requires the participation of General practitioners (GPs). In Germany there is little tradition of research in this field, and GPs are not used to be participants in research. Little is known about German GPs attitudes towards research. Therefore the aim of our study was to assess the willingness of German General Practitioners to participate in primary care research and their attitude towards research in general practice. The results should enable a more successful approach to GPs in further studies., Methods: Cross sectional study using semi-structured interviews with a random sample of 76 General Practitioners who participate in the teaching of medical students at the University of Heidelberg., Results: Despite little experience, over 85 % of GPs appreciated research in their field. Important reasons for scepticism about research were the gap between theoretical research and practical work of GPs and the domination of research by specialists. Main barriers for participation are clinical workload, administrative overload and the newly introduced Disease Management Programs. The highest motivation for GPs to participate in research emanates from the will to substantiate their quality of care with solid research data., Conclusions: Financial incentives and personal support e.g. with study nurses are certainly necessary to establish a research culture and to overcome main barriers against participation. The most successful approach to motivate GPs to participate is to convince them that research documents their quality of care. This data may reflect the facts on which the financial resources are provided in the future health care system.

The Deutsche Forschungsgemeinschaft (DFG) serves all fields of sciences and the arts by financing research projects. The DFG can support science by funding of individual grants, priority programmes, research groups and collaborative research centers. With these mechanisms of funding, clinical research is also supported. Some structural aspects of clinical research and a few thoughts for the improvement of clinical research are presented.

Surgical research can only be effective if there is good cooperation between clinical and basic researchers. Surgeons should be given the opportunity to practise surgical research as a full-time job for several years. We present part of the data obtained from all surgical departments of German universities concerning the organisation of their surgical research.