An Oxford University study published in the British Medical Journal (BMJ) has shown that EU clinical trial reporting requirements are not being adhered to.
Since 2017 the European Commission has required all trials on the EU Clinical Trials Register (EUCTR) to log their results within 12 months of completion. However the study indicated that of the approximately seven thousand trials which should have reported, only half had done so.
The study indicated that compliance was particularly poor amongst non-commercial organisations (11%), and noticeably higher amongst organisations conducting larger numbers of trials (the quarter of organisations with the fewest trials were 18% compliant versus 78% for the top quarter). Trials run across multiple countries also had higher reporting compliance (34% for single-country trials versus 79% for those run in three or more countries).
This could be indicative that smaller organisations, particularly non-profits, do not have processes in place to ensure proper reporting, or are simply not clear on their trial-reporting responsibilities. In contrst the list of organisations with highest compliance rates is overwhelmingly dominated by large pharmaceutical firms.
In addition to non-compliance, the study also highlights issues with inconsistent reporting, including contradictory end-date reports, or failure to include an overall end-date for the trial. The authors had to discard the data for 29% of trials as it was not clear whether the trial was due to report.
In addition to the study results reported in the BMJ, the authors are maintaining an updated compliance database which can be browsed here.