[Animal experiments in biomedical research. An evaluation of the clinical relevance of approved animal experimental projects].

According to the German Animal Welfare Act, scientists in Germany must provide an ethical and scientific justification for their application to the licensing authority prior to undertaking an animal experiment. Such justifications commonly include lack of knowledge on the development of human diseases or the need for better or new therapies for humans. The present literature research is based on applications to perform animal experiments from biomedical study groups of three universities in Bavaria (Germany) between 1991 and 1993. These applications were classified as successful in the animal model in the respective publications. We investigated the frequency of citations, the course of citations, and in which type of research the primary publications were cited: subsequent animal-based studies, in vitro studies, review articles or clinical studies. The criterion we applied was whether the scientists succeeded in reaching the goal they postulated in their applications, i.e. to contribute to new therapies or to gain results with direct clinical impact. The outcome was unambiguous: even though 97 clinically orientated publications containing citations of the above-mentioned publications were found (8% of all citations), only 4 publications evidenced a direct correlation between the results from animal experiments and observations in humans (0,3%). However, even in these 4 cases the hypotheses that had been verified successfully in the animal experiment failed in every respect. The implications of our findings may lead to demands concerning improvement of the licensing practice in Germany.