Bianca Piachaud-Moustakis

Despite the evolution of clinical trial regulation in Europe over the past 20 years, the continuing split in responsibilities across multiple jurisdictions and diverse practices has led to a decline in the number of meaningful multi-state trials taking place across the region. As a result, the European Union (EU) has come to be viewed as a less favorable environment for conducting clinical research.

Among the various official responses that have been put forward to address the deficiencies in the European clinical trials landscape is the launch of the Accelerating Clinical Trials in the EU (ACT EU) initiative in January 2022, co-led by the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA), and the European Commission (EC). ACT EU is described as “a business change initiative designed to transform the EU clinical research environment with top-quality scientific advice and optimized regulatory oversight that is conducive to conducting large trials that deliver decisional evidence.”

The new initiative builds on the Clinical Trials Regulation (CTR) (Regulation (EU) No 536/2014), and the related Clinical Trials Information System (CTIS), as well as the EMA/HMA Network Strategy to 2025, and the EC’s Pharmaceutical Strategy for Europe.

 These strategies aim to future-proof the current regulatory framework by supporting industry in promoting research and leveraging decentralized technologies, while at the same time, maintaining the highest level of clinical trial data protection, robustness, and transparency.

The ACT EU strategy paper lists 10 priority actions for 2022/2023 (see 

 In August 2022, the EC, HMA, and EMA announced a revised ACT EU workplan covering the 2022–2026 period, which outlines in detail what will happen over the next four years.

 The extension of the initiative and the launch of the workplan was, in hindsight, to be expected given the extensive scope and challenge of implementing all of the 10 priorities in just two years. The extended workplan highlights key focus areas such as innovation in clinical trials, robust methodologies, and collaboration across stakeholders. It also makes the targeted objectives more transparent, as all of the priorities and deliverables are described in detail in the revised document.

 ACT EU Strategy 10 priority action points (4–6). 

For 2023, the workplan lays out deliverables and timelines that include:

 The aim is to establish a support process specifically targeted at academic sponsors to make the EU a more attractive region in which to conduct clinical research.

 Particular attention will be paid to CTIS and CTR training activities, as well as troubleshooting any issues encountered by clinical trial sponsors.

 This will be established in 2023 to facilitate the evolution of the clinical trials environment through regular dialogue between all stakeholders, including patients, healthcare professionals, and academia, and to find practical solutions that will enable and drive change.

 ACT EU will support not only the adoption but also the implementation of revised EU guidelines in technology and clinical trial design.

Facilitation of innovative clinical trial methods.

 The ACT EU initiative will issue guidance on the conduct of Decentralised Clinical Trials (DCTs) by the end of 2022 and publish a methodology roadmap to identify and prioritize key advances in clinical trial methods.

The COVID-19 pandemic served to highlight the discrepancies in regulatory requirements between EU member states and the complications that ensue when submitting multi-state trial applications, especially when many of these applications are processed at a national level. As a result, one of the principal objectives of the ACT EU initiative is to “better coordinate scientific advice as a complement to trial authorization and to support marketing authorization and access throughout the medicine life cycle, with the efforts outlined aimed at increasing efficiency through ensuring a clear and unified European position on clinical trials in strategic matters at the international level.”

From the end of January 2023, sponsors will have to use CTIS to submit all new clinical trial applications given that from January 2025, the EU Drug Regulating Authorities Clinical Trials database will cease operations, thereby necessitating that all new and ongoing studies will need to be transferred to CTIS. While this will no doubt incur a significant management change, CTIS is a game-changing initiative that will allow for a single submission to be made, and support the flow of information between clinical trial sponsors, EU Member States, European Economic Area (EEA) countries, and the EC.

 It is therefore hoped that the long-term benefits of working with regulatory bodies and having better clarity over submission and approval timelines will outweigh the short-term operating inefficiencies that will ensue as a result of the proposed changes.

1. O’Donnell, P. Playing Catch-up with Europe’s Decline in Attracting Clinical Trials. 

 Online, 17 July 2023.
2. EMA. Accelerating Clinical Trials in the EU (ACT EU). 

, accessed 9 Aug. 2023.
3. Medidata. Accelerating Clinical Trials in the EU (ACT EU): Focus on Decentralised Clinical Trial Innovation. 

. 18 Nov. 2022.
4. HMA. Accelerating Clinical Trials in the EU (ACT EU). Workplan, August 2022.
5. Eglovitch, J.S. EU Adopts 10-part Workplan to Guide the Acceleration of Clinical Trials. 

, RAPS, 30 Aug. 2022.
6. Research Quality Association. EMA—ACT EU: Creating a Better Environment for Clinical Trials Through Collaboration. 

, News Release, 5 July 2023.
7. EMA. Accelerating Clinical Trials in the EU: Publication of 2022-2026 Workplan. News Release, 30 Aug. 2022.
8. Fultinaviciute, U. ACT EU State of Play: EMA’s Headway to Transform Clinical Trials. Clinical Trials Arena, 15 Nov. 2022.
9. Burton, P. 4 Key Priorities for the European Medicines Agency in 2023. Pharma Boardroom, 30 May 2023.

Bianca Piachaud-Moustakis is lead writer at Pharmavision, Pharmavision.co.uk.

Articles

The ACT EU initiative aims to develop the European Union further as a competitive center for innovative clinical research.