[Benefit-risk evaluation of new drugs as a basis for decisions on prioritization in hematology/oncology: methodical challenges and problem-solving strategies].

Innovations in the drug treatment of cancer patients pose several medical and ethical challenges. The increasing incidence and prevalence of cancer, in combination with the availability of new and usually highly expensive anticancer drugs, are associated with a significant increase in the general costs for the treatment of cancer patients. Therefore, the development of scientific strategies for judgments on benefits is indispensable. In this paper, the authors analyze the benefit assessment and the benefit-risk assessment as a foundation for decisions on prioritization in hematology and oncology. In a first step, regulatory aspects and shortcomings regarding the design of clinical trials in oncology before and after approval of anticancer drugs are identified as factors that contribute to difficulties in establishing the effectiveness of new drugs entering the health care market. The authors will conclude with suggestions for the improvement of benefit-risk analyses and the generation of scientific data necessary for such analyses.