The European Medicines Agency (EMA), European Commission (EC) and the Heads of Medicines Agencies (HMA) have sent a letter to clinical trial sponsors reminding them of the requirement to publish the results of all clinical trials conducted in the European Union (EU) in the EudraCT database. Since September 2018, the EMA has also been reminding sponsors of trials with missing results of their reporting obligations on a monthly basis.
In accordance with 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 paediatric clinical trials.
The EMA stated that “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.”
As of April 2019, the EMA noted that only 68.2% of the completed clinical trials in EudraCT have posted results in compliance with the Clinical Trial Regulation. The EMA have found that compliance with the publication requirements was higher for commercial sponsors (77.2%), compared with non-commercial sponsors who only published 23.6% of study results on time.
To read the letter to stakeholders regarding the requirements to provide results for authorised clinical trials in EudraCT, please click here.
To read the press release from the EMA calling for all sponsors to publish clinical trial results in the EU database, please click here.