February 2024 CTAG Meeting: Key Updates for European Clinical Trials

In the previous post, we explored the Clinical Trial Coordination and Advisory Group (CTAG) and its role in shaping European clinical trial regulations. Now, let's delve into the key takeaways from the February 2024 CTAG meeting, as outlined in the meeting minutes [Source: https://ec.europa.eu/transparency/expert-groups-register/core/api/front/document/103385/download], with a particular focus on the implications for Regulatory Affairs and Study Start-Up professionals.

As a Regulatory Affairs & Study Start-Up Consultant, I'm particularly interested in two main topics discussed in the meeting minutes:

• The changes proposed for the submission of Substantial Modification (SM) and Additional Member State Concerned (AMSC) applications.
• The updates for sponsors navigating the transition from the Clinical Trials Directive to the Clinical Trials Regulation (CTR).

The European Medicines Agency (EMA) is proposing changes to expedite the review process for two specific scenarios:

• Substantial Modifications (SMs): These are significant changes to an ongoing clinical trial that require regulatory approval (previously called "substantial amendments"). The EMA aims to streamline the SM application process while ensuring compliance with the Clinical Trials Regulation (CTR)

• Additional Member State Concerned (AMSC) Applications: These applications involve extending a clinical trial to additional EU member states beyond those initially included. The EMA is looking to leverage the Clinical Trial Information System (CTIS) to simplify the AMSC application process.

These proposed changes aim to accelerate clinical trial initiation, potentially leading to faster access to new treatments for patients. However, upholding the high standards of the CTR for patient safety and data integrity remains a priority.

While acknowledging that Article 11 of the CTR allows for initial submission of Part I only (focusing on administrative and scientific details), the CTAG emphasizes the importance of sponsors submitting complete applications, including both Part I and Part II information (detailed protocols and investigator brochures) across all participating member states. This ensures all relevant details are readily available for review by regulatory authorities, fostering a smoother and more compliant research process.

The February 2024 CTAG meeting also addressed the ongoing transition from the Clinical Trials Directive to the Clinical Trials Regulation (CTR). Here are two key updates for sponsors navigating this transition:

• Clarity on Part II Documents: CTAG has developed a table outlining the specific Part II documents required for applications transitioning from the Directive to the CTR. This resource will help sponsors understand the new requirements and ensure a smooth transition for ongoing trials

• Communication Campaign for a Seamless Transition: The EMA is launching a communication strategy to support stakeholders during the migration of clinical trials registered in EudraCT (the old system) to the new CTIS platform. This will minimize disruptions and provide clear guidance for a smooth transition process.

The discussions at the February 2024 CTAG meeting highlight the ongoing commitment of regulatory bodies and stakeholders to work together for:

• Streamlining clinical trial processes
• Enhancing regulatory clarity
• Facilitating a smooth transition from the Directive to the Regulation
• Ultimately, ensuring the success of clinical trials in Europe

Staying informed about these evolving topics is essential for all stakeholders involved in European clinical trials. I will continue to provide updates on these and other developments in the clinical trial landscape on www.regulatory.rocks.

What are your thoughts on the updates from the February 2024 CTAG meeting? Share your comments below!

From my perspective, these proposed changes from the EMA are a welcome development. As a Regulatory Affairs & Study Start-Up Consultant, anything that streamlines the application process and reduces submission and approval times benefits both sponsors and patients. Faster approvals for substantial modifications can keep trials on track, and a simpler AMSC application process can expedite access to new treatments across Europe.