Clinical trials in the EU – improving the clinical research environment
Preparing for the new clinical trials regulation
The Clinical Trials Information System (CTIS) development continued in 2021. Following a successful audit and a decision of EMA’s Management Board, the European Commission confirmed that the entry into application of the Clinical Trials Regulation (CTR) and the go-live date for CTIS would take place on 31 January 2022.
The application of the CTR and the go-live of CTIS represents a major milestone for clinical research in the EU and the EEA. CTIS supports the harmonisation of the assessment and supervision processes for clinical trials and will be the single point of entry for all clinical trial applications in the EU/EEA. Throughout the development of the system, Member States and sponsors were engaged to ensure that the system meets user needs. Intensive testing was carried out to guarantee the timely delivery of CTIS.
Throughout 2021, EMA ran a programme of activities to make sure that sponsors and Member States were prepared for the CTIS go-live. This included two large information events for all stakeholders and two targeted training sessions organised for SMEs and academia, supported by a tailored online training module. An event on how sponsor organisations can prepare for CTIS took place on 29 July and was attended by more than 2,400 participants. In addition, a master trainer network was set up, a sponsor handbook and sponsor organisation modelling materials were created, organisation modelling sessions were held with Member States and an extensive online modular training programme was made available.
Finally, EMA, in collaboration with Member States and the European Commission, delivered safety monitoring and coordination tools for the clinical trial Safety Implementing Regulation, which also entered into application on 31 January 2022. The Safety Implementing Regulation lays down the rules for Member States’ cooperation on safety assessment on the basis of the CTR.
Accelerating Clinical Trials in the EU (ACT EU)
In late 2021, the European Commission, the Heads of Medicines Agencies (HMA) and EMA agreed to launch the Accelerating Clinical Trials in the EU (ACT EU) initiative to transform how clinical trials are initiated, designed and run. ACT EU aims to further develop the EU as a focal point for clinical research and to better integrate clinical research in the European health system, for the benefit of patients.
ACT EU will help to achieve the ambitious goals for innovation in clinical trials as set out in the European medicines agencies network strategy to 2025 and the European Commission’s Pharmaceutical Strategy.
The initiative uses the momentum of the CTR to further promote the development of high-quality, safe and effective medicines. ACT EU will reinforce the European environment for clinical trials whilst maintaining the high level of protection of trial participants, data robustness and transparency that EU citizens expect.
The European Commission, EMA and HMA have agreed ten priority actions for 2022/2023, including enabling innovative trial methods, modernising oversight and supporting the modernisation of good clinical practice. One of the priority actions will be to establish a multi-stakeholder platform where all voices, including those of patients, can contribute to enabling better clinical research.
ACT EU is co-led by the European Commission, HMA and EMA. The Agency has overall responsibility for programme management.