Cochrane Germany has issued a statement calling the failure by German universities to make clinical trial results public in line with European transparency rules "completely unacceptable".
The statement follows the release of a report by TranspariMED and BUKO Pharma-Kampagne in late December that showed that at least 477 clinical trials run by German universities were missing results on the European database EudraCT. Many of those trials had not made their results public in academic journals either.
The report was widely covered by national media.
The head of Europe's largest medical association, the Marburger Bund, also issued a statement calling universities' current performance "completely unacceptable"
IQWIG, the German institute tasked with assessing the efficacy and cost-effectiveness of new medicines, called for suspending public funding for universities that fail to make trial results public
A German MEP wrote to the German Minister of Health to ask whether the government is monitoring the submission of results to the database
Two regional parliamentarians submitted a written question about the University of Hannover's trial reporting performance
Jörg Meerpohl, director of Cochrane Germany, said:
"For the work of Cochrane, gap-free access to the complete evidence base is essential. Our systematic reviews aim to assess the complete evidence related to a research question, not just a distorted portion [of the evidence]. On this way can they fulfill their claim to deliver the best possible evidence base for or against treatment options. University medical centers should set a good example in this regard. That they instead evidently make less than ten percent of their study results publicly available within the set [regulatory] timeframe is completely unaccptable."
"Transparency of clinical trial data and results is essential to the good conduct of medical research, to the development of new medicines and medical treatments, to expand scientific knowledge on those medicines and treatments and for patient safety. Ensuring transparency is a matter of drug efficacy and safety, whereby information on clinical trials is publicly disclosed and hence made available to patients, prescribers and researchers.
"The broad access to data is crucial to develop innovation and stimulate further research. Transparency is also a matter of public trust and confidence in the European research community and the EU regulatory system for a safe evaluation and supervision of drugs in Europe. CPME insists that all results of clinical trials, whether they are positive, negative or inconclusive, should be made publicly available."
Experience from the UK suggests that it will take German universities many months to upload their missing study results, in part due to the cumbersome trial reporting interface (which the European Medicines Agency is currently working hard to improve).
Over the coming months, TranspariMED will document German universities' progress in trial reporting, and provide regular updates on related political and regulatory developments on this blog. Stay tuned.