German universities have uploaded the results of 76 clinical trials over the past six months. Universities have uploaded twice as many results over the past six months than during the preceding six years combined.
In December 2019, TranspariMED and BUKO Pharma-Kampagne released a report showing that German universities had a very weak track record in clinical trial publication.
In the wake of strong media coverage, calls for universities to address the issue were issued by:
European parliamentarian Patrick Breyer
Two regional parliamentarians in the state of Niedersachsen
The results of this public and political pressure have been impressive. Many academic medical centers in the country are now tackling their backlogs of unreported trials on the European trial registry EudraCT.
The strongest performers to date are the universities of Heidelberg (16 results posted), Mainz (12 results) and Cologne (9 results).
The full extent of universities’ efforts will only become visible over the coming months, as more and more trial results emerge from their reporting pipelines.
European Union transparency rules require institutions running drug trials to upload the results of all trials listed on EudraCT within a year of trial completion. Posting trial results onto registries protects patient interests, accelerates scientific progress, and reduces costly research waste.
However, enforcement rests with national governments, and so far only Denmark seems to be effectively enforcing the rules.
Compliance by universities across Europe remains weak overall. However, the picture is rapidly changing.
While overall performance remains very weak in key countries such as Belgium, France, Italy, the Netherlands and Spain, some of the best-known universities and research institutions in those countries have recently started to address the issue.
For example, Mario Negri Institute is leading by positive example within Italy. The institute has already achieved a reporting rate of over 88%.
Most Irish and British universities are already performing very strongly because they started fixing the problem in 2018. The three universities dominating clinical research in Austria started the process later, but have all committed to clear their backlogs of unreported drug trials.
Till Bruckner, founder of TranspariMED, said:
“Many leading universities in Germany and beyond are now working hard to fix this problem. Their strong efforts will benefit patients, taxpayers and the medical research community.
"The conversation about academic trial reporting in Europe has completely shifted over the past two years. Patients, taxpayers and research funders have repeatedly made clear that they expect universities to embrace transparency and curb research waste.
"Failing to rapidly make trial results public is simply not acceptable any more. National medicines regulators across Europe should follow Denmark’s positive example and ensure that all universities and pharmaceutical companies comply with transparency rules.”
The BIH QUEST Center recently published a trial reporting manual to help European universities to systematically and efficiently improve their clinical trial reporting.