Optimales Management von klinischen Studien: Welche Organisationsmodelle offeriert die theoretische Analyse, wie sieht die praktische Umsetzung aus?

Background: Germany as a R&D location is encountering a growing competition with other nations. Third-party funds play an important role in financing university hospitals. The pressure on universities to implement efficient structures for clinical research through organizational changes is increasing. Aim: Which organization models for optimal management of clinical studies are offered by a theoretical analysis and how are these models currently implemented in German universities? Method: Theoretical analysis of the interface between universities and industries, as well as of the organizational structure within the university hospital from an economic perspective. Explorative empirical comparison between theoretical results and practical implementation in German universities. Data: Organizational charts from ten “Coordination-Centers for Clinical trials” (KKS) are used for the census. Results: Derived from the theoretical inter-company analysis, the theoretical optimal alternative seems to be a joint venture between the university hospital and pharmaceutical manufacturer, which, however, is deemed not feasible in practice. The existing relationship between the client and contractor should be optimized. The organizational analysis within the university hospital indicated that the conduct of clinical trials should be organized within a “clinical trial department”. This department should be managed within a matrix-project regime and additional staff positions should be made available to co-ordinate central activities. The explorative empirical census shows that only three out of ten KKS can be considered similar to the theoretical model (Dresden, Halle, Cologne). Conclusions: The organization model deduced from the theoretical analysis provides an alternative for university hospitals to optimize the management of clinical trials. This model is partly implemented in German Coordination Centers for Clinical Trials (KKS). Further empirical research should concentrate on outcome-based criteria