EMA Report

Landmark events and continued impetus in the regulation of clinical trials of drugs have been highlighted in the EMA annual report for 2021.

The application of the EU Clinical Trials Regulation (CTU) at the start of 2022 has been hailed as ‘a major milestone’ for research. The regulation harmonises the process for assessment and supervision of clinical trials throughout the EU and aims to increase the scale of carrying out research by offering attractive and favourable conditions along with high standards of transparency and safety for participants throughout the Union.

Also mentioned, was the launch of the Accelerating Clinical Trials Act (ACT EU) late in 2021. The aim of this particular initiative is to ‘build on the momentum of the CTR to further promote the development of high quality, safe and effective medicines”.

The EMA outlines that the initiative is designed to reinforce the beneficial European trials environment, high protection for participants and the transparent provision of robust data. It’s also apparent from the report that it aims to win back studies that are shifting abroad. Priorities under the initiative for 2022/23 include enabling innovative trial methods, modernising oversight, and supporting GCP modernisation as well as establishing a platform where all stakeholders can be heard, including patients, in order to enable better clinical research.

The report also outlines EMA plans to build up European regulatory capability and capacity to ‘deliver robust evidence for benefit-risk decision-making'. This includes projects to strengthen scientific advice on in-development products, market authorisation assessment support and expert advice and data analysis for products already on the market. For example, regulators will to be able to make decisions across the life of a medicine by utilising DARWIN EU – the Data Analysis and Real-World Interrogation Network for real-world evidence on diseases, populations and medicine use and performance, currently in the early stages of development.

The EMA has also set up a ‘Big Data Steering Group’ alongside national authorities which will boost data quality and study methods in areas such as data standardisation, AI, and real-world meta data, for better regulation.

All of these moves are extremely positive for the growth and development of trials throughout the EU and will ultimately lead to a more controlled and transparent environment for clinical research, and better outcomes for all.