Improving the environment for clinical research in the EU
2022 was an important year for clinical research in the EU.
Clinical Trials Regulation
On 31 January 2022, the Clinical Trials Regulation (CTR) entered into application, harmonising the submission, assessment, and supervision processes for clinical trials in the EU.
The changes brought about by the CTR are supported by the Clinical Trials Information System (CTIS), which went live on 31 January 2022, serving as a single-entry point for sponsors and regulators of clinical trials for the submission and assessment of clinical trial data. The system includes a public searchable database for healthcare professionals, patients, and the public at large.
Although the use of CTIS remained voluntary in 2022, over 200 initial clinical trial applications were authorised and more than 200 were under evaluation with the new system at the end of the year. EMA collaborated with clinical trial sponsors and Member States to identify and resolve technical issues, provide proactive hands-on support to the CTIS user community and strengthen the system ahead of its compulsory use for initial clinical trial applications on 31 January 2023.
EMA’s activities to ensure stakeholder readiness and facilitate the transition to CTIS included:
- an extensive revision of the online modular training programme taking into account user feedback;
- three large information events for stakeholders and three targeted training sessions for SMEs and academia;
- 23 regular training webinars with sponsors;
- a multi-stakeholder workshop in December 2022, to allow for the sharing of experiences and feedback.
In addition, draft guidance on the protection of personal data and commercially confidential information contained in documents uploaded in CTIS was published for public consultation in 2022.
ACT EU – towards more and better clinical trials in the EU
In parallel with the implementation of the Clinical Trials Regulation, in January 2022 EMA, together with the European Commission (EC) and the Heads of Medicines Agencies (HMA), launched 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.
This initiative will help to achieve the ambitious goals for clinical trials and innovation as set out in the European medicines agencies network strategy to 2025 and the European Commission’s Pharmaceutical Strategy, and uses the momentum of the CTR to further promote the development of high-quality, safe and effective medicines.
An ACT EU steering group was established, and thematic teams were formed from across the three organisations. In August 2022, the steering group adopted the ACT EU 2022 – 2026 multi-annual workplan, introducing key deliverables for each of the initiative’s ten priority actions, which among others, will facilitate innovation in clinical trials, enable stakeholder engagement through the establishment of a multi-stakeholder platform and enhance regulatory network collaboration.
One of the focus areas of ACT EU in 2022 was the implementation of the CTR and to understand how it is transforming the clinical trials environment. To do so, since April 2022 monthly statistics on the authorisation of clinical trials in the EU have been published. ACT EU also published a survey to understand the issues faced by sponsors submitting trials under the CTR. A report summarising the findings and subsequent actions taken by key Network groups has been published.
ACT EU made progress in developing methodology to support innovation in clinical trials. In June 2022, guidance was published on planning and conducting complex clinical trials for clinical trial sponsors and marketing authorisation applicants. Later in the year, following a multi-stakeholder event, a recommendation paper on the use of decentralised elements in clinical trials was published.
The key actors in clinical trials scientific advice in the EU came together under ACT EU to clarify the scope of scientific advice activities by providing a mapping of voluntary procedures available within the European medicines regulatory network. The EU Innovation Network (EU IN) collaborated with ACT EU to launch the second phase of its pilot on simultaneous national scientific advice (SNSA), which focuses specifically on scientific advice to facilitate clinical trials within the EU.