It comes to medicines for Multiple sclerosis, therapies after kidney transplantation, the treatment of children with a high risk of diabetes, and much more: According to a report by the organisations Transparimed and Buko Pharma-campaign is not published, much of the medical research results of German universities in a timely manner in the EU database EudraCT.
Who landing a clinical trial in the database, is obliged to publish the results no later than one year after the completion of the study, there. If this does not happen to be the rules is a violation of the EU, says the report.
According to the survey, 35 German universities have been deposited in the database of 477 studies, shown to be complete for at least a year. However, only in 32 cases – just under seven per cent – were published the results of the study. In 445 cases, the information was missing, however, at the time of the evaluation.
This may well have negative consequences for patients and for further research: Results of a clinical study, for example, that a therapy helps less, as previously thought, should Doctors know this, so you can take it into account in future decisions. For other researchers it is also important to plan about further studies accordingly.
First, NDR, WDR and SZ had reported about the Report. The German universities, therefore, less to the requirements as the institutions in other countries, universities in Europe have published an average of 63 percent of the study’s results in the EU database.
The report revealed large differences between the German universities While the University hospital of Münster, published in 61 percent of the study results within the time-limit in the database, not the deeds of other universities in this part at all.
How can the failure be explained? According to the NDR “‘t talk your way out, on request, a number of German universities, thus, the release binding”. Objected to by the Federal Institute for drugs and medical devices (BfArM), however, speaks.
The University of Freiburg announced the publication in the EU database would be “very expensive”. Several also referred to the fact that they would upload the results in the German database. However, this is with a view to international research is not sufficient.
The head of the Institute for quality and efficiency in health care (IQWiG), Jürgen Windeler, said the NDR, the public funding of studies should be made dependent on whether previously completed projects have been published in the prescribed manner.