While there is much focus on transparency in the Clinical Trial Regulation, it’s important that sponsors understand their data transparency obligations for trials that were conducted in the EU and that will be wrapped up under the Clinical Trial Directive.
Sponsors are expected to ensure results from those studies that do not need to transition to CTR are posted on EudraCT. While EudraCT will be replaced with Clinical Trial Information System (CTIS), the database will remain open for the submission of trial result summaries after 30 January 2025. In accordance with the mandatory requirement in place since 2014, sponsors will have to post results within 6 or 12 months of the end of the trial, depending on the type of trial involved.
From EudraCT to CTIS
For those trials authorised under the CTD that will continue to have at least one active site in the EU after 30 January 2025, sponsors will need to ensure that a summary of results are transitioned to the CTIS as soon as possible.
Your legal representative is responsible for ensuring all of this data is completed and should be reminding you to ensure you meet your trial data obligations. And EMA has made clear it considers data transitioning obligations an urgent priority.
What are the consequences of not posting data?
While it remains to be seen whether EMA will penalise companies that fail to publish data from trials completed before the transition, it can’t be ruled out. Certainly, in the US, the FDA has begun fining sponsors that are not compliant with reporting requirements. It is worth noting that as a sponsor you are obliged to report trial summary results.
An important but perhaps overlooked consideration is that if sponsors do fail to publish results, they potentially will not be able to use reference data from their trials in a future Marketing Authorisation Application. So, for example, if a trial were to start up at a later date, data from a clinical trial completed before the final transition date, but that had not been posted to EudraCT, may not be admissible.
Furthermore, for any sponsor, the relationship you develop with the health authorities is important. Since you are required to post your trial results when you’re conducting studies in the EU, it is advisable that you meet those obligations and maintain good relations with the regulators.
“While it remains to be seen whether EMA will penalise companies that fail to publish data from trials completed before the transition, it can’t be ruled out.”