[Therapy optimization studies torn between science and funding]

There is no doubt that clinical studies are valuable cornerstones in the development of rational diagnostics and therapy, for the patients' safety, for quality assurance as well as for the development of a body of evidence in medicine. Well recognized multicentric study groups are active in several medical disciplines in Germany. Public funding resources however are miserable as compared to other countries. For example in hematology and oncology funds are almost exclusively available by private foundations as the Deutsche Krebshilfe only. Additionally physicians and institutions who are actively promoting clinical studies have to pay charges for patients' insurance and for registration of studies by the authorities. Furthermore there are increasing difficulties obtaining reimbursement for patients' care in clinical studies. In this context outdated regulations of the German Sozialgesetzbuch V lawbook play an important role. In summary a pronounced reform deficit paired with bureocratic tendencies has become manifested. The most important demands are in this situation: a reliable and realistic regulatory basis for treatment-related clinical studies has to be created. Studies on treatment strategies with registered drugs have to be free from the obligatory patients' insurance which is required for study with non-registered drugs. It has to be clarified that in these studies some regulations of good clinical practice as obligatory external monitoring and source data verification are not feasible and will not be required. The Sozialgesetzbuch V has to be adapted and the actual ban of clinical studies in private practice has to be ended. Treatment related clinical studies have to be free from charges of ethical committees and regulatory authorities. Thereby the financial overload of clinical studies could be reduced and some motivation for further bureocratic proliferation is removed. Finally a longterm, reliable funding resource has to be created independently from the pharmaceutical industry. A possible model could be a foundation for treatment-related studies which is financed by public funds and by funds from the reimbursement companies.