It is about drugs for multiple sclerosis, therapies after a kidney transplant, the treatment of children with a high risk of diabetes and much more: According to a report by the organizations Transparimed and Buko Pharma-Campaign, a large part of the medical research results of German universities do not reach the EU provided for them in time Database EudraCT released.
Anyone who created a clinical study in the database was obliged to publish the results there no later than one year after the study was completed. If this does not happen, it is a violation of EU rules, the report says.
According to the study, 35 German universities have stored 477 studies in the database that have been proven to have been completed at least one year ago. However, the study results were only published in 32 cases - just under seven percent. In 445 cases, however, the information was missing at the time of the evaluation.
This can have negative consequences for patients and for further research: If a clinical study shows that therapy is less helpful than previously thought, doctors should know this so that they can take it into account in future decisions. It is also important for other researchers, for example to plan further studies accordingly.
First, NDR, WDR and SZ reported on the report. German universities are therefore less likely to follow the guidelines than institutes in other countries: Universities in Europe would have published an average of 63 percent of the study results in the EU database.
The report reveals major differences between German universities: while the University Hospital of Münster published 61 percent of the study results in the database within the deadline, other universities did not do so at all.
"Very expensive"
How can the failure be explained? According to the NDR, "numerous German universities are getting away with the request that the publication is not binding". The Federal Institute for Drugs and Medical Devices (BfArM) contradicts this.
The University of Freiburg announced that publication in the EU database was "very complex". Several also indicated that they would upload the results to the German database. However, this is not enough in terms of international research.
The head of the Institute for Quality and Efficiency in Health Care (IQWiG), Jürgen Windeler, told the NDR that public funding for studies should be made dependent on whether previous projects have been published in the prescribed manner.