The New Clinical Trial Regulation in the European Union – What’s New?

On January 31, 2022, the European Union (EU) moved from Clinical Trial Directive (CTD) 2001/20/EC and adopted the new Clinical Trial Regulation (CTR) which is intended to streamline clinical trials in the EU and make Europe a more competitive destination for clinical trials, without compromising patient safety and data validity. All sites that run clinical trials in the EU must now embrace the new CTR and get familiar with the changes and requirements therein imposed. 

What are the Objectives of the EU CTR?

The main objective of the new EU clinical trial regulation is to grant EU countries a competitive edge in conducting clinical trials. Currently, the EU falls behind countries such as China, Japan, and the U.S in hosting clinical trials. Structures suggested by the CTR will enable the EU to change this. Such structures support a shift from site-based to remote monitoring of clinical trials. This will facilitate multi-national trials, especially in the recruitment of participants for clinical trials on rare diseases. The structures include remote monitoring, home visits, and data collection at home, in pharmacies, or at physician offices. To achieve this, it is necessary to have a system in place to monitor the different sites and synchronize the information remotely. The system should also allow the trial sponsor and other stakeholders to have virtual access at all times. The Clinical Trials Information System (CTIS) database has been created to expedite this.

The New Clinical Trials Information System (CTIS)

The new EU-CTR has leveraged Information Technology (IT) to create a centralized database that allows single electronic submission of clinical trials instead of the previous submission of multiple dossiers. By January 2025, sponsors will have to upload all clinical trial information to the CTIS portal which was launched on January 31, 2022. The CTIS objectives are to facilitate communication between trial sponsors and the EU regulatory authorities as well as to provide the public with accessibility to EU clinical trials through a searchable website. 

All data on the CTIS is publicly available as the EU-CTR prioritizes transparency, but with few exceptions. Thus, it is the onus of the sponsors to ensure patient confidentiality at all points of data submission. However, exemptions are made for personal data and confidential commercial information. Trial sponsors have already started using CTIS. 

CTIS will synchronize trials across the EU and hence result in greater benefits to patients. By eliminating the need for submitting multiple dossiers and making different applications to each country, the CTIS also promotes efficiency. 

CTIS Challenges

The CTIS presents two major challenges for clinical trial sponsors:

• A steep learning curve and possible errors due to the complexity and scope of the system as well as the multiplicity of users.
• In the short term, there’s likely to be a slower activation of clinical trials.

Till the end of January 2023, new clinical trials have to shift to the CTIS. With this deadline fast approaching, the European Medicines Agency (EMA) has recommended that sponsors and member states implement and flag potential issues in CTIS so that they can be addressed before the deadline. EMA, together with Heads of Medicines Agencies (HMA), will drive the Accelerating Clinical Trials in the EU (ACT EU) Initiative. This initiative gives 10 suggestions that should be adapted by CROs, sites, and sponsors within the next 3 years, with full implementation being completed by January 2025. 

Tri-Phasic Implementation of CTR

Phase 1 (January 31, 2022 – January 31, 2023): Clinical trials can be submitted either under the legal framework of EU-CTD or EU-CTR.

Phase 2 (January 31, 2023 – January 31, 2025): Clinical trial applications should be submitted under EU-CTR. However, ongoing clinical trials approved under EU-CTD will continue to be regulated under EU-CTD. 

Phase 3 (January 31, 2025 onwards): All clinical trials will be regulated under EU-CTR.

How Does a LIMS for Clinical Trial Management Support the New CTR?

A Laboratory Information Management System (LIMS) for clinical trial management helps laboratories to manage trial samples and metadata, automate and streamline processes, and integrate with instruments. A cloud-hosted LIMS for clinical trial management supports remote access to clinical trial data which is a key requirement of CTIS. With a LIMS for clinical trial management in place, CROs can easily meet the new CTR requirements.

EU CTR Supports Multinational Clinical Trials 

The new CTR will help the EU overcome funding challenges that are inherent in the EU-CTD. The CTIS will improve efficiency and collaboration and also promote remote monitoring of multisite clinical trials. The full implementation of the CTR will grant the EU a competitive edge over non-EU countries for hosting multinational clinical trials.