[Medical ethical challenges of phage therapy-informed consent, study design and therapeutic trial].

Abstract

The antibiotics crisis is increasing interest in bacteriophages and related therapeutic approaches. The translation of phage therapy into clinical application faces various ethical challenges. These include the patient's informed consent based on patient information as well as open questions regarding an ethically sound study design. In addition, further ethical problems arise from the current situation of phage therapy in Germany with regard to equity of access. This article reflects on the three aspects of phage therapy mentioned above. The results show that phage therapy does not pose any requirements for patient information that could not be solved by adapting the information provided. Questions regarding an adapted study design arise against the background of the placebo dilemma, possible resistance to antibiotics and the expected small number of study participants. An attempt can be made to respond to these challenges by adapting the study design. As a result, the studies deviate from the gold standard, which is randomized, controlled and double-blind studies. A balance must be struck here between evidence requirements and the protection of study participants. From an ethical point of view, the protection of participants must be given greater weight. The current situation of phage therapy in Germany poses an ethical problem, as both the individualised therapeutic trial and the resulting medical tourism that can be observed stand in the way of the demand for fair access and distribution. In order to overcome this status, the magistral prescription represents a possible interim step until clarity has been gained about an appropriate study design.