To address the European Union’s drop in global share of clinical trials over the past decade, stakeholders are working together to deliver a dynamic, agile, responsive EU clinical trials environment. As Katarina Nedog of the European Federation of Pharmaceutical Industries and Associations (EFPIA) points out in the March 2025 edition of DIA’s Global Forum magazine, the Accelerating Clinical Trials in the EU (ACT EU) initiative, launched in 2022, already provides a multistakeholder platform for collaboration, but greater acceleration is needed to turn its potential into measurable progress.
Over 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.
