Transition to new European clinical trials info system starts slowly
At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.
Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.
As far as the number of trials for which a decision has been issued in CTIS by the EU member states is concerned, 4 non-commercial apps have received a decision so far, and 0 commercial apps, although the vast majority of apps submitted are still under review.
“Currently one multinational clinical trial has a decision (authorised) in CTIS with 14 Member States Concerned,” the report notes. “An average will be provided in future reports when more than one multinational trial has a decision recorded.”
By Jan. 31, 2025, all ongoing trials approved under the current EU trials directive will be governed by the new trials regulation, and have to be transitioned to the new CTIS.
Meanwhile, to help trial sponsors fulfill their transparency requirements under the new regulation, EMA said it is preparing guidance on the protection of personal data and commercially confidential information in CTIS.
And later this summer, EMA said it will host a CTIS-focused event on lessons learned in the first six months from the CTIS launch.