January 31, 2022
New European Clinical Trials Regulation Goes Live
Changes are intended to simplify multinational trials and improve transparency
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The way clinical trials are conducted in the EU is changing from today as the Clinical Trials Regulation comes into effect. The aim is to create an environment that is favorable to conducting clinical trials in the EU, with the highest standards of patient safety and increased transparency of trial information.
The regulation will include a new streamlined portal for trial sponsors and regulators. The Clinical Trials Information System (CTIS) will enable sponsors to submit one online application via a single online platform for approval to run a clinical trial in several European countries. Sponsors will no longer have to submit trial applications separately to each of the national authorities and ethics committees, making it more efficient to carry out such multinational trials.
CTIS will contain the centralized EU portal and database for clinical trials foreseen by the Clinical Trials Regulation, set up and maintained by the European Medicines Agency (EMA) in collaboration with the member states and the European Commission. CTIS will also provide a single place where results can be published and will include a searchable database for healthcare professionals and the public.
View the CTIS press briefing
The regulation will bring member states closer together in the area of clinical trials. In turn, this will inspire further confidence and trust among citizens, who are at the center of clinical research.
Stella Kyriakides
European Commissioner for Health and Food Safety
CTIS will support the day-to-day business processes of member states and sponsors throughout the lifecycle of a clinical trial and provide regulatory oversight of clinical trials and tools for supervision and monitoring.
It will also contain collaboration tools, workflow and document management capabilities, accessible via individual workspaces:
- The Sponsor Workspace will aid sponsors in preparing and compiling data to submit to the system for assessment by member states. It will allow sponsors to manage users and user roles within their organizations, compile clinical trial application dossiers for new and updated trials, search and access clinical trials, and record clinical trial results.
- The Authority Workspace will support the activities of member states and the European Commission in overseeing clinical trials. It will allow member states to manage tasks related to the assessment of clinical trials, collaborate within and between member states, and record inspections of sites and clinical trials.
- The Public Website will allow members of the public to access detailed information on all clinical trials conducted in the EU, in all official EU languages. The website's features include advanced search, the ability to download data and reports, and notification of site updates and announcements.
CTIS brings EU clinical trials closer to healthcare professionals and patients. It will make it easier for patients to find opportunities to take part in clinical research.
Andrzej Ryś
Director at the European Commission
The Clinical Trials Regulation goes live with a “stepwise” transition:
- From January 31, 2022, sponsors can decide whether to use CTIS for their application for an EU clinical trial, but it's not mandatory. Applications for clinical trials submitted outside CTIS up to January 31, 2023 will be reviewed and assessed following the old procedure.
- From January 31, 2023, all applications to start a new EU clinical trial must be submitted via CTIS.
- Before January 31, 2025 all EU clinical trials authorized using the old system but still ongoing will have to be transferred to CTIS.
The new CTIS system will facilitate conduct of large multinational trials addressing key health issues, like cancer. It will ensure robust and statistically valid results leading to better treatments for patients.