Biomedical innovations and clinical research. Summary

Clinical research is an important part of the development of new medicines, medical devices and other therapeutic methods, such as surgical procedures. It includes various types of human studies that - with different focuses - test the efficacy and safety of new products and procedures. The data obtained are used on the one hand for applications for market approval of new procedures, but on the other hand also to improve health care practice by answering questions from clinical practice and using already introduced procedures in a more targeted and efficient way. In particular, the large patient studies that are required for the marketing authorisation of medicinal products are associated with a great deal of effort and considerable costs. On the other hand, they also mean a not inconsiderable factor for the labour market for researchers and study personnel. Despite internationally recognised guidelines that are largely cast in law, there are significant differences in their implementation at the national level. The existing leeway opens up the possibility for countries to optimise the conditions for clinical research at the location, but there is also the danger that clinical research could migrate to countries with more favourable conditions. Subject and objective of the study German policy has taken important steps to strengthen clinical research in Germany, but the industry continues to complain in part about competitive disadvantages compared to other countries. Although the number of clinical trials has increased in recent years, the increase has been significantly greater in some competing countries. In the long run, this could have an impact on employment and on the supply of innovative medicines to patients, as new products are preferentially introduced in those countries where clinical trials have already taken place. Traditional methods in clinical research are also being challenged by novel, mostly biotechnological therapeutic methods, e.g. gene or cell therapies or monoclonal antibodies, or by nanomedicine, for which the existing knowledge is still relatively limited and which may therefore pose particular risks for patients and study participants. In the case of these novel procedures, scientific development is advancing very rapidly, so that the framework conditions, especially for the protection of the subjects participating in clinical trials, must be reviewed again and again and, if necessary, adapted to current challenges, but without hindering the conduct of clinical trials in Germany too much. The description and evaluation of the various location conditions for clinical research and an in-depth analysis for the area of biomedical innovations were the goal of the project completed in June 2009.