What is Clinical Trials Regulation?

The Clinical Trials Regulation refers to the legal framework governing the conduct of clinical trials in the European Union (EU). The Clinical Trials Regulation (EU) No 536/2014 was adopted by the European Parliament and the Council of the EU in April 2014 and came into full application on January 31, 2022. It is designed to simplify the approval process, increase transparency, and ensure the safety of clinical trials conducted within the EU, while also enhancing the overall efficiency of the clinical trial system.

What is the significance of Clinical Trial Regulation in the Clinical Trial landscape?

Streamlined Approval Process: Under the CTR, clinical trial approval is handled through a centralized procedure via the CTIS. Once the application is submitted, the concerned EU member states have 45 days to provide feedback or raise concerns, which facilitates quicker decision-making. The approval time for multinational trials is now harmonized across member states, reducing discrepancies between countries and delays in study initiation.

Increased Transparency:The regulation requires greater public access to information about clinical trials, including the publication of trial results, both positive and negative. This aims to improve transparency and accountability within the clinical research community and reduce the issue of publication bias. The regulation allows for better monitoring of trials through the use of both pre-authorization and post-authorization inspections. Member states can conduct inspections to ensure that trials are conducted in compliance with GCP and EU standards.

Risk-Based Approach: The CTR introduces a risk-based approach to the assessment of clinical trials. This means that the regulatory process is more tailored to the level of risk associated with the trial. Trials with higher risks may face more extensive review, while low-risk trials benefit from more rapid approval processes.

EudraCT Database and Public Disclosure: The CTR mandates that all clinical trial data be registered and publicly available through the EudraCT database, which is a platform for clinical trial information in the EU. This includes trial design, results, and adverse event data, which helps in making clinical trial results more accessible to the public and healthcare professionals.

How is the transition from the Clinical Trials Directive (CTD) to the Clinical Trial Regulation (CTR) being implemented?

Timeline and DeadlinesThe Clinical Trials Regulation (CTR) was officially applied on January 31, 2022. This marked the start of a transitional period for ongoing clinical trials previously governed by the Clinical Trials Directive (CTD). This period spans three years, during which sponsors have the flexibility to choose whether they continue to follow the CTD or switch to the CTR. By January 31, 2023, however, all new clinical trials were required to be fully compliant with the CTR. For existing clinical trials under the CTD, a final deadline was set for transitioning to CTR compliance by January 31, 2025, or earlier if the trial concludes before that date.

Transition ProcessThe transition process is designed to ensure continuity and alignment with the new regulatory standards. Ongoing clinical trials that comply with the core principles of the CTR can transition smoothly with minimal adjustments. The transition includes using the new Clinical Trials Information System (CTIS), a unified platform for submitting and managing clinical trial data across the EU. For trials under the CTD that have substantial amendments, sponsors will need to update their protocols and ensure that trials are in full alignment with the CTR requirements, which may include enhancing safety reporting, informed consent processes, and data transparency

Responsibilities and OversightSponsors play a critical role in ensuring that their clinical trials meet the updated CTR requirements within the transition timeline. They are responsible for updating their applications and trial documentation in line with the CTR’s harmonized processes, such as submitting through the CTIS. National authorities and ethics committees have the responsibility to monitor compliance with the CTR, conducting inspections where necessary to ensure that trials are conducted in accordance with the new regulation. In cases where compliance is not met, corrective actions may be required, which could involve halting the trial or making adjustments to the trial’s processes.

DDReg’s Capability

With the introduction of risk-based approaches, improved transparency, and expedited approval procedures, the Clinical Trials Regulation (CTR) completely transformed the clinical trial environment in the European Union. At DDReg, we specialize in supporting sponsors to achieve seamless CTR compliance. From navigating the Clinical Trials Information System (CTIS) to ensuring the trials meet all updated safety, transparency, and ethical standards, our team is equipped to guide through every step of this transition.