The vast majority of universities are failing to comply with EU rules on the reporting of clinical trial results, according to a registry analysis (PDF).
EU rules require sponsors to register clinical trials and post results within 12 months of completing a study. Those rules came into force in 2014, but there is evidence many European universities are yet to adapt to the requirements.
To assess the situation, four R&D transparency campaign groups analyzed records uploaded to the EU clinical trial registry by 30 European universities. The analysis found results are missing for 83% of the clinical trials performed by these leading research centers, putting them in violation of European law.
The situation is worse than that data point suggests, as the result is skewed by the U.K. Universities in the U.K. reported results for 69% of clinical trials. Excluding these strong performing sites from the analysis reduced the reporting rate to 7%.
None of the French, Italian, Norwegian or Swedish universities included in the data set reported their results. The list of universities that failed to report results includes some well-regarded institutions with strong ties to the biopharma industry. Sweden’s Karolinska Institutet failed to report results on all 24 trials for which data are due, according to the analysis, and Vita-Salute San Raffaele University is late reporting on all six of its studies.
Only five universities based outside the U.K. reported results on more than 10% of their trials. And no university outside of the U.K. reported results on more than one-third of their studies.
The divergence between most of Europe and the U.K.—where two universities reported 93% of their results—suggests ways to improve reporting across the continent. Reporting rates in the U.K. have shot up as a result of major funders of R&D committing to transparency and political pressure.
As the BMJ reports, regulators in countries including Denmark and Germany lack the power to sanction universities for failing to report results. But the experience of the U.K. shows non-regulatory forces such as the threat of losing funding can compel universities to improve. The European Medicines Agency is trying to drive up the reporting rate by sending reminders to universities.
The campaign groups that performed the analysis are calling for the factors that increased reporting in the U.K. to spread across Europe. Specifically, the activists want more research funders to sign up to the World Health Organization joint statement on public disclosure of results from clinical trials as well as for national governments to monitor reporting and punish universities that break the rules.