European Regulators Urge Sponsors to Publish Clinical Trial Results
The European Medicines Agency (EMA), European Commission (EC) and the Heads of Medicines Agencies (HMA) on Wednesday released a letter sent to clinical trial sponsors last month reminding them that they are required to publish the results of all clinical trials conducted in the EU in the EudraCT database.“Transparency and public access to clinical trial results, whether positive or negative, are fundamental for the protection and promotion of public health. It assures trial subjects that their voluntary participation in clinical trials is useful and that the results have been collected and reported for the benefit of all,” EMA says.
Under the Clinical Trial Regulation (Regulation EU No 536/2014), sponsors of EU-based clinical trials are required to publish the results of their trial within one year of completion or within six months of completion for pediatric trials.
However, EMA says that as of April 2019, only two-thirds (68.2%) of the completed clinical trials in EudraCT have posted results in compliance with the regulation.
According to EMA, there were 57,687 clinical trials registered in EudraCT as of April, roughly half of which were marked as completed (27,093).
“Out of these completed trials, 18,432 should have had results posted; sponsors were in compliance with the publication requirements for 68.2% (12,577) of the trials, however results were still lacking for 31.8% of them (5,855),” EMA says.
EMA also noted that compliance with the publication requirements was much higher for commercial sponsors (77.2%), while non-commercial sponsors, such as academia, trailed, with less than a quarter (23.6%) of study results published on time.
This finding is in line with the findings of a study published in The BMJ last year that found commercial sponsors “were substantially more likely to post results” than non-commercial sponsors such as universities. The study also found that sponsors who conducted a large number of trials were more likely to comply with the publication requirement than sponsors who conducted a smaller number of trials.
In addition to the co-signed letter, EMA says it has been reminding sponsors of trials with missing results of their reporting obligations on monthly basis since September 2018.
EMA, Letter