[Clinical studies in oncology. Relevance, design, ethical considerations]

Clinical research in oncology includes the evaluation of diagnostic, prognostic and therapeutic parameters in order to establish standards for the different tumor entities. Prerequisite is the retrospective and prospective analysis of large patient groups with established statistical methods. New potentially better strategies have to be compared in randomised studies with the respective "gold standard". The central role of clinical studies for evaluation and optimisation of therapy can be considered as moral obligation to included the maximal possible number of patients in clinical studies. However, only a small number of tumor patients in Germany is treated in controlled clinical studies. Reasons are lack of organisational structures, but also ethical considerations.

In this article several models for clinical studies are discussed with respect to their statistical significance, indication, and potential ethical objections.

Aim of the discussion is to increase the acceptance of the necessity of clinical studies for evaluation and optimisation of therapeutic options in oncology.