While universities in other countries are rapidly progressing in making their clinical trial results public, some universities in Germany still lag far behind.
Data from the EU Trials Tracker shows that the five worst performers in Europe are all German universities. Between them, these universities have sponsored 95 clinical trials that are due to post results onto the European trial registry. They have not posted the results of a single trial.
Hannover Medical School has the worst track record in Europe.
Out of 53 trials total, 26 trials were verifiably completed more than one year ago. European Union transparency rules oblige Hannover Medical School to upload the results of those trials onto the EudraCT database, but to date, the university has not uploaded the results of a single one of those trials.
BfArM and IQWIG demand that universities post trial results
In June 2019, the German medicines regulator BfArM issued a statement “explicitly supporting the demand” of the European Medicines Agency that trial sponsors comply with their long-standing obligation to upload the results of all clinical trials onto the registry.
In 2018, IQWIG’s director Jürgen Windeler called for sanctions on universities that fail to upload the results of their trials:
“The fact that tax-funded universities are not fulfilling their legal obligations is particularly regrettable. There are substantial deficits in investigator-initiated trials with regard to data transparency – and sanctions are seemingly required to quickly change this. On several previous occasions, the Institute experienced that clinical trial investigators at universities withheld data.
"The fact that clinical trials are not registered and their results are not reported is not a trivial offence. Rather, ethical and scientific standards are being violated, because the benefit and harm of medical interventions can only be correctly assessed on the basis of complete data. Only then can physicians and patients decide on the best-possible alternative.”
There are many good reasons why posting clinical trial results onto the European registry is mandatory.
Research shows that the results of over a quarter of trials run by German universities are never made public, in any form. Registry reporting minimises the risk of a trial never reporting its results and thus becoming costly research waste.
In addition, posting results onto registries accelerates medical progress because the 12-month timeline permits far more rapid results sharing than the slow academic publication process allows, and results posted onto registries typically give a more comprehensive and accurate picture of patient-relevant trial outcomes than corresponding journal articles do.
Many universities in the rest of Europe - and some in Germany - are now rapidly moving to clear their backlogs of unreported clinical trials.
For example, the University of Münster has already posted 11 trial results, achieving a reporting rate of over 60%.
The data above indicate that Hannover Medical School, University of Cologne, University Erlangen-Nuremberg, University Hospital Tübingen and Heidelberg University Hospital remain far behind the curve.
This presentation explains how German universities can improve their clinical trial reporting. A collection of transparency tools is available on the TranspariMED website.