Assessment of innovations in clinical research: strengths and potentials for improvement of research in Germany

Clinical research is a central link in the development chain of new treatment methods; scientifically, it belongs between basic science and health services research. It spans from the first application of a new substance or device in humans to the main proofs of its efficacy and safety. Economically speaking, it absorbs almost half of the total expenditures for the research and development of a new drug and represents a significant factor in the labour market for researchers and study personnel. Also, through participation in clinical trials, patients gain early access to new treatment methods, while on the other hand they are placed at higher risk for undesired side effects. Politics have taken significant steps to strengthen clinical research, but the pharmaceutical industry continues to complain about competitive disadvantages. Despite internationally recognised and, to a large extent, legally codified guidelines there are still significant national differences in implementation. In addition, traditional practices in clinical research are challenged by novel, mainly biotechnological therapeutic methods for which our current knowledge base is rather limited and which therefore entail a higher risk for patients or trial participants. The following paper summarises a report for the Office of Technology Assessment at the German Federal Parliament (TAB). Based on current regulations, scientific literature and expert interviews, current challenges and solution strategies for clinical research will be analysed in terms of an international comparison.