ver the past decade, Europe’s share of global clinical research has declined. Even as the total number of global commercial trials rose by 38%, the European Economic Area share of commercial trials fell from 22% in 2013 to 12% in 2023. This has a real impact on patients: it represents an estimated 60,000 fewer people accessing trials involving an EEA country, and 20,000 fewer places available in EEA-only trials. These latest data, published in October 2024, reflect a long-running trend that must be reversed and illustrate that the European research system is slow and fragmented. Despite these challenges, there is a strong sense that all contributors to EU clinical research are committed to ensuring Europe fully realizes its potential as a great place to conduct trials. These contributors must turn this commitment into measurable results without delay. There has been progress in some areas, mixed with discouraging news on European competitiveness in clinical research.

Europe begins from a position of strength, with excellent research institutions, global opinion leaders in clinical research, and leading healthcare systems. It has been a vital source of scientific and medical progress for centuries and strives to remain an important global player in conducting clinical trials. The problem is in converting these strengths into a more efficient and attractive research landscape.

The global environment is increasingly competitive. With large competitors, such as the US and China, growing their share of clinical trials, and smaller competitors such as Japan, South Korea, and Australia using flexibility to their advantage, EU stakeholders must pull together to unlock their full potential. To do this, we must foster dialogue, while working together to resolve problems swiftly at the national and European level.

Time to ACT Faster

The good news is that Europe already has a platform for multistakeholder collaboration which, with renewed urgency from all sides, can be a catalyst for concrete progress. The Accelerating Clinical Trials in the EU (ACT EU) initiative was launched in 2022 by the European Commission, the European Medicines Agency (EMA), and Heads of Medicines Agencies (HMA). It seeks to create a favorable environment in the life sciences through harmonization, innovation, and collaboration with stakeholders. ACT EU builds on the momentum of implementing the EU Clinical Trials Regulation (CTR) and the Clinical Trials Information System (CTIS), exploring ways to incorporate new approaches and sources of data that can enable dynamic and robust evidence generation.

The first two years of the ACT EU initiative have already delivered advances on several fronts and have inspired hope for a new era in EU clinical research. This promise has not yet been realized, but ACT EU provides a solid foundation on which to build.

Fundamentally, ACT EU has brought the European clinical research community together to focus on a vision for 2030 in which clinical evidence is guided by shared data, knowledge, and expertise. It is a future where innovative trials with harmonized/interactive platforms are at the heart of the regulatory system; a future in which we see increased harmonization and collaboration among Member States and ethics committees, supplemented by real-world evidence and new methodologies where appropriate. High levels of transparency will remain central to this system so that societal trust is preserved and, crucially, the patient voice should play a strong role in the work of authorities and industry at every stage.

Supporting Transparency, Ethics Reviews, and Collaboration

ACT EU has inspired progress on a number of priority areas which are of interest to the European clinical research community:

• Revised CTIS transparency rules focus on key documents and rely on redaction as a tool to protect commercial data.
• The COMBINE project is working to ensure a smoother interplay between regulations on trials for medicines, medical devices, and in vitro diagnostics (IVD).
• Collaboration between ethics committees and competent authorities to align on best practices and address industry needs for greater predictability and consistency.
• A Multi-Stakeholder Platform (MSP) Advisory Group has been created, co-chaired by a regulator and another stakeholder, and has hosted a methodology workshop and an event on data analytics.
• Enhancing scientific advice through two new pilot projects: one to support more consistent advice on marketing authorization and/or clinical trial applications, and another on technical and regulatory aspects of trials prior to submission.

In addition, an Action Plan is in development to support trials run by noncommercial sponsors. This includes mapping existing noncommercial trials at the national and EU level, optimizing the regulatory helpdesk to support academic sponsors, and helping noncommercial sponsors to transition trials from the CTD to the CTR via the CTIS.

Looking Ahead

The achievements to date are encouraging. However, the high hopes that characterized the early stages of the ACT EU initiative have not yet come to fruition. It is imperative that the effort invested by all stakeholders in recent years pays dividends. To achieve this together, we must take immediate steps to (1) proactively move ahead with key aspects of ACT EU by building on existing legislation and initiatives and (2) urgently work on policies and measures to ensure that Europe is restored to its proper place as a global clinical research hub.

A number of initiatives have been devised at the national and EU levels in recognition of the need to simplify Europe’s complex clinical research ecosystem. It is vital that these efforts are aligned to ensure a common focus with measurable goals.

Immediate steps to accelerate progress

• Eliminate any additional national requirements that go beyond the EU Clinical Trial Regulation
• Improve CTIS functionalities and user experience
• Streamline and harmonize the way Ethics Committees work across Europe to avoid unnecessary complexity and prolonged timelines
• Facilitate the cross-border access to clinical trials (EU-X-CT initiative)
• Enhance direct communication between regulators and industry
• Remove bottlenecks faced by sponsors running combined studies involving medicines, IVDs, and/or medical devices in line with the COMBINE program strategy, such as “all in one” coordination across the medicine and device sectors across EU Member States.

The ACT EU workplan 2025-2026 is a step in the right direction. It establishes regular meetings of the MSP Advisory Group which provides a platform for defining shared goals. This must include concrete Key Performance Indicators (KPIs) with agreed timelines against which progress can be measured.

The first meeting of the MSP Advisory Group in March 2024 kick-started collaborative work, while pilots on consolidated advice and workshops on CTR transition show our proactive mindset in action. An ACT EU multistakeholder workshop in October 2024 provided a valuable opportunity for stakeholders to come together and review progress. It is also encouraging to see the EMA establish its first focus group on CTR implementation and the CTIS. This provides a basis for moving forward, and we hope it will inspire the establishment of further topic-specific working groups to drive progress between workshops.

Europe has begun a new journey towards better, faster, optimized clinical trials from a position of strength. To deliver on the optimism inspired by the launch of ACT EU, we need a fresh sense of urgency. The challenges are real and growing and can only be solved together through a common platform. We have established a solid platform for collaboration. Now we must be brave enough to harness its full potential.