EU ODD Significant Benefit: Lessons from a Competitive Market
Published Feb 26, 2025
EU Clinical Trials Regulation: A New Era Begins
Published 30th January 2025
The EU Clinical Trials Regulation (CTR) came into full effect on January 31st, 2025, marking a pivotal moment for European clinical research. This milestone represents years of collective efforts to harmonise the clinical trial review and approval process across the European Union, improve transparency, and strengthen patient safety and data integrity. The transition period has offered valuable insights and highlighted both the opportunities and challenges for sponsors and regulators as they prepare for full compliance.
Key Learnings from the 2022-2025 Transition Period
The EU Clinical Trials Regulation transition period, which began in January 2022, served as a testing ground for implementing the new requirements. During this three-year phase, sponsors, investigators, and regulators adapted to the Clinical Trial Information System (CTIS) and aligned their processes with CTR requirements ahead of its full implementation. These key insights emerged from this crucial adaptation period.
Achieving True EU-Wide Harmonisation: Progress and Challenges
The EU Clinical Trials Regulation (CTR) prioritizes harmonising clinical trial processes, documents, and transparency requirements across all EU member states. Submitting a single application under consistent rules with a coordinated assessment procedure has successfully simplified multinational clinical trial submissions in the European Union. However, despite the regulation’s goal to standardise trial applications, some member states maintain additional national requirements, including specific supplementary documents. This practice impacts the goal of a single, streamlined submission process – a challenge expected to diminish as the CTR reaches full implementation.
CTIS: Transforming Clinical Trial Management Across Europe
The Clinical Trials Information System (CTIS) has been critical in harmonising the clinical trial application review process across the EU. This system aims to provide a single platform for submissions, RFIs, and approvals. Despite its clear impact on improving efficiency, it is an entirely new system that requires extensive training and process adaptation. For sponsors still struggling with this new system, which continues to evolve, DLRC has extensive experience in providing necessary training and support.
The need for comprehensive training has been evidenced as submissions have occurred. This applies to both sponsors and regulators. One key challenge has been the way modification submissions are handled within CTIS. With each modification submission, the entire historical package (not just the documents being updated) is available to the regulators in the system, which has led to confusion. We have seen RFIs raised on documents that were not part of the modification package.
CTIS also introduced stricter timelines. Some member states have struggled to meet these due to resource constraints or internal procedures.
Transparency in Clinical Trials: Balancing Disclosure and Protection
Enhanced transparency in clinical trials is undeniably a positive development. The provision of lay summaries demystifies trials for patients, making complex research accessible and understandable. This openness empowers patients and fosters collaboration and innovation amongst sponsors within the clinical trial landscape.
However, introducing new transparency requirements alongside implementing the new CTIS system has led to additional challenges. Many stakeholders are still navigating the system. This has led to occasional errors such as documents with signatures or documents marked “not for publication” being available within CTIS for public viewing. These missteps highlight the need for continued education and guidance to manage sensitive information appropriately.
One notable improvement introduced during the transition period was the reduced number of documents automatically made public. This update has limited the inadvertent upload of documents not meant for public access. It has enabled sponsors to focus on sharing only relevant and meaningful information. This achieves a better balance between openness and confidentiality.
Supporting Innovation: How Small and Academic Sponsors Can Thrive Under CTR
Introducing a new system has required a steep learning curve for many small and academic sponsors. It required them to adapt to new processes, requirements, and timelines. Unlike larger organisations with dedicated teams and resources, smaller sponsors often have limited capacity to manage the administrative and regulatory demands of the CTR. Once again, highlighting the need for training and support.
By addressing these gaps, the broader community can help to ensure that smaller sponsors remain active in the clinical trial landscape.
CTR: Ensuring Compliance in the New Regulatory Landscape
Full implementation of the CTR is now mandatory as of 31st January 2025, but reports show there are likely to be trials that still have yet to be transitioned. The EMA ‘CTIS Newsflash’ report in October showed a considerable spike in transitions (due to the deadline date of 16th October), almost 900! For reference, previous months were submitting ~500 transitions. Even though this number dropped significantly in November to ~200 transitions and December to ~150, it shows that transition submissions have continued past the recommended deadline. It will be interesting to track the outcomes of those trials that could not transition and receive approval in time for the regulation to take place (ultimately making their trials non-compliant).
Strategic Action Plan: Your Path to CTR Success
With the CTR in full effect, the importance of collaboration, education, and resource-sharing cannot be overstated. Particularly for smaller sponsors navigating these changes with limited capacity. The focus will remain on ensuring compliance, addressing hurdles, and supporting all parties in embracing the CTR’s full potential. This milestone is not just a regulatory obligation but the date to start creating a more inclusive, innovative clinical trial landscape.
Essential Next Steps for Sponsors:
Training: Continuous education on CTR requirements and CTIS remains a top priority for sponsors and regulators.
Process: Streamlining internal processes to align with CTR timelines and requirements will be crucial for efficient trial management.
Collaboration: At DLRC, we continue to engage with industry groups, regulators, and patient advocacy organisations to foster a shared understanding and address emerging challenges quickly.
Ready to navigate the EU Clinical Trials Regulation with confidence?
Trust DLRC’s proven expertise in clinical trial management and regulatory compliance. Our experienced team has successfully guided dozens of companies through CTR implementation.
Start your CTR journey today – reach out to our expert consultants at hello@dlrcgroup.com or explore our specialised services below.
