On January 13, 2022, the EU launched an initiative, ACT EU, that aims to transform and accelerate how clinical trials are initiated, designed, and conducted. The initiative is led by the European Commission (Commission), the Heads of Medicines Agencies (HMA), which is a network of all of the EU Member States’ medicines agencies, and the European Medicines Agency (EMA).
ACT EU comes just a few days before the new EU Clinical Trials Regulation (Regulation 536/2014) will become applicable on January 31, 2022. This new regulation will significantly change how clinical trial sponsors will apply for, conduct, report, and advise outcomes and results for clinical trials in the EU.
ACT EU aims to further the EU medicines agencies’ 2025 strategy, for example, by supporting innovation and digitalization in clinical trials and providing a framework to allow more complex trial designs, including the use of data analytics and real-world data.
The initiative is also part of the Commission’s Pharmaceutical Strategy that was released in November 2021 and that has as key goals to increase cooperation in scientific advice, to address unmet medical need, to facilitate the design of clinical trials, and to ensure that innovation matches the needs of patients and of the national health systems.
What does ACT EU propose?
According to the initiative, the current environment for clinical trials is challenging. Current data, including during the COVID-19 pandemic, shows that most clinical trials in the EU are small single Member State studies instead of impactful multi-Member State trials. ACT EU therefore details the objectives to develop the EU as a focal point for clinical research, to further promote the development of high-quality, safe, and effective medicines, and to better integrate clinical research in the EU health systems.
What will ACT EU mean for clinical trials sponsors in the EU?
ACT EU will be co-led by the Commission, the HMA, and the EMA. The objectives of ACT EU are to
- optimize the environment for clinical research in the EU by, inter alia,
- strengthening coordination on clinical trial authorization
- supporting the conduct of large-scale multinational trials
- reducing administrative burdens
- strengthen clinical trials that deliver decisional evidence for unmet medical needs, for rare diseases, and on vaccines and therapeutics for public health crises and pandemics
- offer excellent and coordinated scientific advice as a complement to trial authorization and to support marketing authorization
What are the next steps?
A number of priority actions have already been set for 2022-23, including
- the successful implementation of the EU Clinical Trials Regulation and its implementing acts
- the implementation of the Good Clinical Practice (GCP) modernization being led by the development of new GCP guidance by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
- the development of key guidance on, inter alia, clinical trials affected by artificial intelligence and machine learning tools, complex trials, decentralized clinical trials, and the interface between the EU In Vitro Diagnostics Medical Devices Regulation (Regulation 2017/746) and the EU Clinical Trials Regulation
Clinical trial sponsors who wish to conduct trials in the EU should follow these developments and consider leveraging the opportunities they bring such as increased access to scientific advice as well as access to a single authorization (part I of the assessment) to conduct clinical trials in the EU.
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