Are European universities failing to report clinical trial data in a timely manner?
European Union (EU) regulations mandate that sponsors of interventional clinical trials registered on the European Clinical Trials Database (EudraCT) should publish their results on EudraCT within 12 months of trial completion (6 months for paediatric trials). Certain details, including trial protocols and data subsets, are then made accessible to the public via the EU Clinical Trials Register (EUCTR). Despite these regulations, a recent joint report on clinical trial transparency by TranspariMED, BUKO Pharma-Kampagne, Test Aankoop and Health Action International identified that 83% of eligible clinical trials run by 30 European universities were missing results on the EUCTR. The results and implications of the report are discussed in detail by Nic Fleming in a news article published in Nature.
Fleming highlights that in the worst case an institution reported data from only 7% of the 188 trials they were due to have reported on. Furthermore, universities running eligible trials in four European countries (France, Italy, Sweden and Norway) had not posted any results. The author of the full report, Dr Till Bruckner (TranspariMED), also notes that the situation has likely been underestimated, as many of the old trials listed on EUCTR as ‘ongoing’ may have completed, but their status and results have not been updated.
Fleming has observed a similar situation in the US with regards to trial reporting. A recent study identified 25 US universities that were in violation of US trial disclosure law, which requires sponsors of certain applicable clinical trials of FDA-regulated products to post clinical trial data within 12 months of trial completion.
However, it’s not all doom and gloom – Fleming highlights that three UK universities (University of Oxford, King’s College London, and University College London) performed significantly better than the rest of Europe with regards to trial reporting, publishing 81–93% of results due.
As a reminder to us all, he warns of the implications of failing to report clinical trial data by noting that “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”.
Summary by Emma Evans PhD, CMPP from Aspire Scientific
With thanks to our sponsors, Aspire Scientific Ltd and NetworkPharma Ltd
Leave a Reply