Suchergebnisse

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.

BACKGROUND: January 2019, the House of Commons' Science and Technology Committee sent letters to UK universities admonishing them to achieve compliance with results reporting requirements for Clinical Trials of Investigative Medicinal Products by summer 2019. This study documents changes in the clinical trial policies and Clinical Trials of Investigative Medicinal Product reporting performance of 20 major UK universities following that intervention. METHODS: Freedom of Information requests were filed in June 2018 and June 2020 to obtain clinical trial registration and reporting policies covering both Clinical Trials of Investigative Medicinal Products and all other clinical trials. Two independent reviewers assessed policies against transparency benchmarks based on World Health Organization best practices. To evaluate universities' trial reporting performance, we used a public online tracking tool, the European Union Trials Tracker, which assesses universities' compliance with regulatory Clinical Trials of Investigative Medicinal Product disclosure requirements on the European Clinical Trial Register. Specifically, we evaluated whether universities were adhering to the European Union requirement to post summary results on the trial registry within 12 months of completion. RESULTS: Mean policy strength increased from 2.8 to 4.9 points (out of a maximum of 7 points) between June 2018 and June 2020. In October 2018 the average percentage of due Clinical Trials of Investigative Medicinal Products that had results available on the European trial registry across university sponsors included in the cohort was 29%. By June 2021, this had increased to 91%, with 5 universities achieving a reporting performance of 100%. All 20 universities reported more than 70% of their due trial results on the European trial registry. INTERPRETATION: Political pressure appears to have a significant positive impact on UK universities' clinical trial reporting policies and performance. Similar approaches could be used to improve reporting ...