[Open questions in the drug therapy of tumors with new active substances]

At the time of market authorization and/or the expansion of indication of new oncology drugs, it is often not possible to reliably measure the relevant benefit for the patient. The conception of the clinical studies, on which the market authorization and/or expansion of indication is based, orients itself primarily at the regulatory requirements of the regulatory authorities. In addition, their results are frequently published only incompletely or some time after the end of the clinical study. To clarify these outstanding questions regarding the individual treatment of patients, independent,science-initiated clinical studies after the market authorization are required. However, the execution of these studies is obstructed due to insufficient financial means as well as by regulations and the low evaluation of such studies by the academia. Further challenges result from the high costs of innovative oncologic therapies, which burden the resources of the statutory and private health insurance providers(GKV, PKV) who are confronted with an aging population and a rising prevalence of tumor cases. Independent post-market authorization clinical studies need to be completed in order to ensure a need-oriented and efficient treatment with new oncologic substances. New perspectives result by connecting the reimbursement of the costs of innovative therapies by the GKV and PKV to the generation of evidence in the context of clinical studies, thus improving the medical care of tumor patients as well as the efficient handling of limited health resources.