EU Launches Long-Awaited Clinical Trials Regulation and CTIS Database
A new consolidated, online clinical trials database that becomes active today in Europe will allow drug sponsors in the EU to run clinical trials in all 27 member states with a single documentation filing.
The Clinical Trials Information System (CTIS) is a website that sponsors will be required by EU regulation to use to submit trial applications for drugs, add new member states to existing applications and update trials on its online database. The site will also allow them to submit documentation updating their trial dossier, reply to requests for information from member states and make trial notifications, such as when trials launch, recruitment begins, trials conclude, serious breaches occur and results summaries are ready. The site can also be used to search for clinical trials using a number of criteria.
The EU’s accompanying set of regulations, the Clinical Trials Regulation (CTR), also comes into effect today and harmonizes submissions, data assessment and supervision processes for trials across the EU and in the three European Economic Area (EEA) countries — Iceland, Liechtenstein and Norway.
In the past, sponsors had to file individual applications with each member country. That’s led to fragmented trials that often are conducted in just a single country, limiting the data that eventually show up in approval applications submitted to the European Medicines Agency (EMA). Creating a single process portal should go a long way toward diversifying and expanding datasets, said Emer Cooke, EMA’s executive director.
The cornerstone of the new EU regulation, the CTIS is the single-entry point for clinical trial regulators and sponsors. EudaMed is CTIS’ counterpart in the EU for device trials. Cooke said the CTIS system was tremendously complicated to create and, in fact, its birth pangs delayed the launch of the CTR for several years.
“I think it is fair to say that we underestimated the complexity of the system, what it would take to combine all the existing national approaches and make sure that we could have a coalescence in a single approach that will now serve 30 countries,” Cooke said.
Over the past decade, European regulators have seen more and more North American data and less European data in new drug applications. It’s a reflection of the difficulty of running trans-state trials that had to conform to different standards of data collection, he said. The challenge sometimes forced sponsors — who could be in any country — to cherry-pick the European data.
Unlike the U.S. registry, ClinicalTrials.gov, CTIS will integrate both clinical trial application and public study registry processes, Sweeney noted. “[CTIS is] really this one-stop shop, single application.”
EU member states will begin using the new system immediately. Drug trial sponsors, however, may use the old process or the new until Jan. 31, 2023. Studies approved under the outgoing Clinical Trials Directive need to transition to the CTIS by Jan. 31, 2025.
The European Commission said it will release the URL for the new database on Jan. 31 at 9:00 a.m. Central European Time (3:00 a.m. EST).