Deutsche Universitäten machen Ergebnisse klinischer Arzneimittelstudien unzureichend öffentlich – Das sollte sich ändern

The results of all clinical drug trials should be published promptly and nonselectively after trial completion. The publication of results appears as a central ethical rule in the Declaration of Helsinki of the World Medical Association. German university hospitals are increasingly being criticized for not meeting these requirements sufficiently. In this article, different forms of publication of clinical drug trial results are discussed (summary results on registries and journal articles) and the current performance of German university hospitals is analyzed. Three registries and databases for clinical studies were examined for publication of summary results: the European Union Clinical Trials Register (EUCTR), the US registry ClinicalTrials.gov and the exclusively German language portal PharmNet.Bund. Positions of different stakeholders are outlined and possible steps for improvement are proposed. German university hospitals do not sufficiently fulfil their regulatory and ethical obligations regarding the publication of clinical drug trial results. Two years after the study completion date, two thirds of the studies listed on ClinicalTrials.gov that were completed from 2010–2014 had not yet published results in scientific journals and only 4.7% had posted summary results in the registry. In the European trial registry, the publication rate in the form of summary results has been found to be less than 7%. Less than 15% of relevant entries in the PharmNet.Bund database have results available. In order to improve the reporting performance of German university hospitals, political will and commitment of the hospitals themselves are needed. The benefits of access to all clinical drug trial results for public health and science far outweigh the (marginal) additional investments that university hospitals have to make to ensure that all their trial results are made public in line with regulatory and ethical requirements.