[Funding and sponsorship of clinical trials in oncology]

The lack of clinical trials represents a bottleneck in the future of the German health care system. Although central organizations as the G-BA (Federal Joint Committee), the IQWiG (Institute for Quality and Efficiency in Health Care) or the INEK (Institute for Hospital Reimbursement), which were established during the last years as central boards for the decision process in health care, use the results of high-quality trials as basis of their decisions, the off-label use as an implicit way of clinical trial promotion by German sickness funds to reduce the cost of care in this special setting has at the same time been combatted in recent years.Thereby, an important basis for the development of oncological therapies through clinical studies was abolished and completely impeded. Also, the underlying conditions of investigator-initiated clinical trials caused more effort because of new legislation. The trend of prioritization in the German health care system based on short resources and the use of study-based evidence for decision-making must lead to the establishment of a new and effective financing and funding of clinical trials. Sickness funds must also be involved in this funding. G-BA and IQWiG, who are castigators of the quality and sponsoring of investigator-initiated clinical trials, must in conclusion postulate basic conditions for successful financing and funding of clinical trials in consideration of their duties and responsibilities.