January 2022 marks a major turning point for clinical trials in the EU. The Clinical Trials Regulation (Regulation (EU) No 536/2014) comes into application on 31 January 2022, with the aim of harmonizing assessment and supervision processes. This will happen through the new Clinical Trials Information System (CTIS), which is being launched at the same time. And a joint initiative by the European Commission (EC), Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) will drive a transformation in the way trials are done in the EU.
In this blog post, we’ll look at each of these elements and what they will mean for clinical trials.
The Clinical Trials Regulation
The Clinical Trials Regulation (Regulation (EU) No 536/2014) is applicable from 31 January 2022. It repeals the previous EU Clinical Trials Directive (EC) No. 2001/20/EC and related national legislation.
The new regulation will being many benefits to trials conducted in the EU. Multinational trials will be easier to run, and sponsors will be able to expand trials into additional EU Member States more easily.
This will be especially helpful for rare disease trials, which often need to recruit participants from multiple countries.
The application process will happen in two parts – part I for scientific and medical product documents, and part II for national and patient-related documents. The process will run centrally through the CTIS. However, Member States will remain independent – “The authorisation and oversight of clinical trials remains the responsibility of Member States, with EMA managing CTIS and supervising content publication on the public website.”
The change won’t happen overnight – clinical trial sponsors will have a one-year transition period. This means that until January 2023, it’s possible to apply to carry out a clinical trial using existing systems. From January 2023, all new applications must go through the Clinical Trials Information System (CTIS).
What about existing trials that are still running in a year? Clinical trials can be active for several years, and taking this into account, ongoing trials will have until January 2025 to switch to using the CTIS.
The Clinical Trials Information System (CTIS)
The new regulation relies on the CTIS – a portal and database for all EU clinical trials. The CTIS will be maintained by the European Medicines Agency (EMA) in collaboration with the EC and EU Member States.
The CTIS aims to push the EU to the forefront of clinical trials internationally. One of its main functions will be to increase transparency, by making “information on the authorisation, conduct and results of each clinical trial carried out in the EU […] publicly available.” CTIS will act as the single point of entry for submissions. All trial information shared as part of the submission will be stored in the system, and the CTIS will make relevant information publicly available. This will lead to greater efficiency, including by preventing “unnecessary duplication of clinical trials or repetition of unsuccessful trials.”
The CTIS will be the central system for sponsors to use throughout the course of the trial. It will have collaboration tools, and workflow and document management capabilities, and everything will be accessible through workspaces – for the sponsor and the authorities. It can be challenging to adapt to a new system; to make it easier, you can access training through an online modular training program run by the EMA.
In January 2022, the European Commission announced a new initiative to transform clinical trials: Accelerating Clinical Trials in the EU (ACT EU). The initiative aims “to further develop the EU as a focal point for clinical research, further promote the development of high quality, safe and effective medicines, and to better integrate clinical research in the European health system.”
ACT EU has been launched to coincide with the regulation and CTIS, ushering in a new era of clinical trials in the EU.
The strategy paper sets out ten priority actions for 2022/2023, including analyzing clinical trial data with the aim of supporting evidence-based decision making, mapping existing initiatives and aligning various groups, and delivering a clinical trials training curriculum.
Taken together, the regulation, CTIS and ACT EU aim to make clinical trials in the EU more efficient, effective, and better for patients
Are you ready to start a new clinical trial in the EU? If you have questions or need support navigating the new regulation, contact us.