Cochrane Belgium, together with TranspariMED, Test Aankoop and Kom op tegen Kanker, recently released a report detailing the status of clinical trial transparency in Belgium.
The report used data collected on the EU Trials Tracker, which monitors the status of clinical trials recorded in the EU Clinical Trials Register. According to EU legislation, clinical trial sponsors must post summary results to the register within one year of a study ending (or six months for paediatric trials).
Several clinical trial sponsors in Belgium with overdue results were reminded last year to update the registry. While some then took significant steps to upload missing data, others have made little progress.
22% of verifiably due trials were found to have not yet posted results on the registry. However, it is likely that far more trials are still missing results, since only 292 of 1,098 registered trials are marked as complete – including several which started over 10 years ago and are likely not still ongoing. Results from trials sponsored by universities and hospitals were also found to be missing more often than trials with commercial sponsors.
The paper also calls upon the Belgian medicines regulator, AFMPS, to ensure that information on trials is kept up to date and recommends that research funders in Belgium monitor trial reporting.
A follow-up report is planned in six months to track further progress on this issue.
Cochrane supports clinical trial transparency. We rely on the availability of results from clinical trials to produce high quality and relevant systematic reviews. When trial results are not published, it is not possible to make truly evidence-informed decisions about healthcare, and people can be put at risk of harm.
Interested in learning more on this issue? Free webinar on 16 June
Cochrane Sweden and Lund University are hosting a webinar on clinical trial registration and reporting on 16 June at 13:30-15:30 (CEST).
The session will be an opportunity to learn more about the ethical and legal requirements around trial transparency.