Clinical research in Germany with special focus on non-commercial studies. Summary

Clinical research is of paramount importance both for the development of new medicinal products and other medical treatment procedures and for ensuring and optimising the application of the procedures in routine practice. All resulting clinical studies are regulated by the German Medicines Act (AMG), provided they investigate the efficacy, safety or metabolism of medicinal products with the aim of testing their safety or efficacy. This type of clinical study is referred to as a "clinical trial". Insofar as clinical research is associated with commercial interests - such as the goal of obtaining marketing authorisation for a new active substance - it is initiated and financed by the developer or manufacturer of the preparation or procedure. However, if the commercial expectations associated with the study results are low or non-existent, especially if the product already has market approval, a private-sector sponsor is often not found. Clinical trials without private funding but which are of public interest are referred to as non-commercial clinical research, science-initiated clinical trials or investigator-initiated trials (IIT), sometimes also as therapy optimisation studies. Non-commercial clinical research usually answers questions that have arisen from treatment practice. Often, already approved drugs or medical devices or interventional (e.g. surgical or psychotherapeutic) procedures are the subject of the investigation. Because the questions revolve around the exact conditions of use - for example, the advantages and disadvantages of a combination of different cancer therapies or the identification of long-term side effects or the comparison of two procedures with each other - the manufacturers of the products often have no economic advantage to expect from such studies. Then a non-commercial institution, often the medical faculty of a university, assumes responsibility for the study (it becomes the study's "sponsor"), and the funding must come at least in part from public funds (from the grant for research and teaching or from dedicated project funding) or be provided by foundations. Against this background, TAB was commissioned to systematically record the significance of currently discussed as well as possible further conditions for the practice of non-commercial clinical research in Germany. To this end, a working definition was first established for the object of investigation. In order to describe and assess the initial situation, data on the