Many of Europe’s major research universities are ignoring rules that require them to make public the results of clinical trials.
A report published on 30 April found that the results of only 162 of 940 clinical trials (17%) that were due to be published by 1 April had been posted on the European Union’s trials register. The 30 universities surveyed are those that sponsor the most clinical trials in the EU. Fourteen of these institutions had failed to publish a single results summary.
If three high-performing UK universities are excluded from the figures, the results of just 7% of the trials were made public on time. Campaigners say the resulting lack of transparency harms patients by undermining the efforts of doctors and health authorities to provide the best treatments, slows medical progress and wastes public funds.
“Major universities in continental Europe are clearly not investing the effort required to meet their ethical, scientific and regulatory obligations,” says report author Till Bruckner, of the UK-based transparency campaign group TranspariMED.
A 2004 EU law that came into effect in 2014 requires study sponsors to publish summaries of a trial’s results on the European Union Clinical Trials Register (EUCTR) site within 12 months of the trial’s completion. Updated laws on clinical trials that are not expected to become legally binding until 2020 specify that there should be penalties for institutions that don’t comply with the rules.
The Medical University of Vienna has posted the results of just 7% of 188 trials due, according to the report, making it the institution with the most missing results. No results were available for trials sponsored by any of the universities in France, Italy, Sweden and Norway — a total of seven institutions — included in the analysis.
A spokesperson for the Medical University of Vienna conceded that its administrative efforts to keep the register up to date were “inadequate”. “We are working on minimizing this documentation gap,” he added.
Bruckner says that the true picture is likely to be even worse than the report suggests, because large numbers of old trials listed on the register as ‘ongoing’ may in fact be complete, and their results due, but sponsors or national medicines regulators have failed to update the trials’ status on the EUCTR site.
“Sponsors, in particular from academia, often lack awareness or incentives to post results in the register,” says Fergus Sweeney of the EU’s drug regulator, the European Medicines Agency, which manages the EUCTR. “We clearly still have work to do to improve the situation.”
UK universities in the survey performed significantly better than those in the rest of Europe. The University of Oxford and King’s College London had both published 93% of the trial results due on the register, and University College London had posted 81%. UK universities have rapidly improved their performance following pressure from campaigners, funding bodies and politicians, says the report.
A March report by TranspariMED and US-based Universities Allied for Essential Medicines of leading clinical-trial sponsors in the United States found that about 30% of due trial results were missing from the national trial repository.