German universities have failed to make public the results of 445 clinical trials of medicines on a European database, in violation of European Union transparency rules, a report released today shows.
The outcomes of many of those trials remain completely unpublished and are in acute danger of becoming costly research waste.
German universities’ failure to adhere to scientific best practices and global ethical norms undermines the medical evidence base, slow down the development of new treatments, and put patient safety at risk.
Clinical trial reporting performance by university
The university of Münster is the strongest performer by far, with 61% of results uploaded. All other universities disappoint.
Number of clinical trials still missing results by university
With 68 due trials still missing results, the Charité in Berlin has by far the largest backlog of unreported trials. Seven universities account for half of all German academic trials that are still missing results.
German universities in global comparison
German universities perform significantly worse than their counterparts in other countries. German universities’ results posting rate of 6.7% is far worse than the reporting performance of British and American universities, and well below the average European trial reporting rate of 62.5%.
Trials at acute risk of becoming research waste
Previous research has shown that over 28% of clinical trials run by German universities never make their results public in any form, and thus become research waste. The report discusses several clinical trials in the cohort whose results remain completely unknown. German patients suffering from a variety of conditions, including cancer, multiple sclerosis, and depression, volunteered to participate in these trials, which are at acute risk of becoming research waste.
Recent positive momentum among German universities
On the positive side, many German universities have recently started tackling the problem. For example, the data cited above was gathered in early November 2019. At that point, Hannover university had not uploaded a single trial result. Only one month later, Hannover has already uploaded results for 5 out of its 26 due trials, illustrating that rapid progress is possible.
Four more universities - Charité in Berlin, Freiburg university, LMU Munich and TU Munich - have told reporters from Sueddeutsche Zeitung that they are currently in the process of setting up structures to improve the reporting of clinical trial results
Regular follow-up reports by TranspariMED will track German universities’ progress over the course of 2020 and beyond.
Contradictory messages from German regulators
A surprise finding of the report is that the two German regulators responsible, BfArM and Paul Ehrlich Institut, seem to have been sending contradictory messages to universities about trial reporting rules and expectations.
BfArM has publicly reminded German trial sponsors of their obligation to upload trial results, with reference to long-standing European Union transparency rules.
In contrast, Paul Ehrlich Institut seems to have been telling universities that no action is required.
Following the launch of the report, BfArM reiterated its position: "Transparency in clinical research is indispensable for protecting health and promoting innovation".
IQWIG: Stop giving public money to non-compliant universities
In a first reaction to the report, Jürgen Windeler, who heads 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.
He told journalists from NDR that trial data “have immediate practical relevance” as they can show that a drug works less well, or has more negative effects, than previously assumed. Funding for new university projects should be put on ice “until the results [of past trials] are where they should be,” Windeler demanded.
German universities should establish central oversight over their clinical trial registry entries, adopt policies that reflect WHO best practices, audit existing registry records, and upload missing clinical trial results.
German research funders Bundesministerium für Bildung und Forschung and Deutsche Forschungsgemeinschaft should commit to adopting World Health Organisation best practices in order to prevent further research waste.
BfArM and Paul Ehrlich Institut should monitor compliance, directly contact trial sponsors whose results are overdue, update the status of existing registry entries, and draw up plans to impose fines after the EU Clinical Trials Regulation comes into force.
The German government should use Research Ethics Committee records to monitor whether clinical trials are prospectively registered and upload their results onto registries on time.
Till Bruckner, founder of TranspariMED, said:
“The scale of German universities’ failure to fully report the results of their clinical trials is shocking. Unreported trials harm patients, undermine public health, and waste public funds. Tax money is being wasted on medical research that violates scientific and ethical norms, betrays the trust of trial participants, and benefits nobody because results are not made public. Some universities have recently started addressing this issue, but others still have their heads firmly stuck in the sand. This problem is too costly to ignore. The government must stop giving public money to universities that refuse to tackle research waste, and adopt legislation that ensures that every single clinical trial is registered and rapidly reports its results.”
Jörg Schaaber from BUKO Pharma-Kampagne said:
“The purpose of clinical trials is to improve our knowledge about which therapies are best. It is disappointing that most German universities fail gravely in reporting the results of their research. Every trial that remains unreported is a loss for science, introduces bias into the available evidence, and shows a lack of respect for the patients who participated in the trial.”
Please click on the image below to access the full report by TranspariMED and BUKO Pharma-Kampagne.