Today marks a significant step forward for clinical research in the European Union (EU). The revised rules for the Clinical Trials Information System (CTIS) are now applicable, providing earlier and more efficient access to clinical trial information for patients, healthcare professionals, and other stakeholders.
Key Highlights:
1. Earlier Availability of Information: The new rules eliminate the deferral mechanism that allowed sponsors to delay publishing data for up to seven years. Now, approximately 4,000 clinical trials with issued decisions are publicly accessible through the CTIS search.
2. Increased Transparency: About 500 newly authorised clinical trials will be added to the CTIS portal each month, including ongoing trials transitioned from the Clinical Trials Directive.
3. Balanced Approach: The updated rules ensure transparency while protecting commercially confidential information. Key clinical trial information, flagged as most relevant by patients, is now published early.
4. Enhanced Usability: Additional features will be added to the CTIS public portal in the coming months, improving overall usability for all users.
5. Support for Sponsors: Resources, including a user guide and a comprehensive overview of published data, have been created to help sponsors understand the revised rules. Dedicated support activities are starting with an event on June 20, open to all sponsors of clinical trials.
6. Adopted by EMA’s Management Board: These changes follow a public consultation and were adopted by the EMA’s Management Board in October 2023.
Learn more about how CTIS is transforming clinical trial transparency in the EU: FASTER ACCESS TO CLINICAL TRIAL INFORMATION IN EUROPE
Need help? At Asphalion we are experts in CTIS. Contact us! info@asphalion.com
