A European Union (EU) ruling moving clinical trials across the continent onto a single platform, the Clinical Trials Information System (CTIS), has come into full effect with ‘corrective measures’ for companies with trials that failed to make the move.
The EU’s legislative ruling, dubbed the Clinical Trials Regulation (CTR), puts an end to the three-year transition period under the Clinical Trials Directive (CTD). As part of the transition, the European Medicines Agency (EMA) said over 10,000 clinical trials had been submitted in CTIS since its launch in January 2022. Of those, more than 5,000 trials were transitioned onto the new CTIS from the CTD.
Additionally, the EMA added that trials which are ongoing and have not been moved to the new system may be subject to corrective measures applied by EU member states. Originally sponsors had to begin filing new trials with the system in January 2023.
The main goal of the CTIS system was to create a single unified portal, moderated by the EU body, for sponsors, clinical research organisations and patients across the EU.
A spokesperson for the EMA said: “The full implementation of the CTR strengthens Europe as an attractive location for clinical research.
“The regulation streamlines the processes for the application and supervision of clinical trials, and their public registration: all clinical trial sponsors use the same system and follow the same procedures to apply for the authorisation of a clinical trial, no matter where they are located and which national competent authority (NCA) or national ethics committee they are dealing with.”
The transition comes nearly four years after the body announced that the CTIS system was fully functional following long delays. Last June, it removed the ability for sponsors to defer trial data for seven years in a transparency update.
Whilst the EMA is responsible for maintaining the CTIS, it falls to each European member state to enforce the CTR and ensure trials comply. Overall, implementation has been met relatively positively, but some concerns have been raised that inconsistencies between member states and how they enforce the ruling may cause trial sponsors to drop out of the continent altogether.
In June 2023, four months after EudraCT originally closed down for new trial applications, experts told the Clinical Trials Arena that sponsors were embracing the move to CTIS but that it was ‘half-hearted’ in some instances. A year later, there were still concerns over the system, with sponsors saying interpretation of the CTR remained a pain point.
