Clinical trials in Europe are entering a new era. The new ACT EU 2026–2027 work programme, launched by the European Commission, the European Medicines Agency (EMA), and national regulatory authorities, goes far beyond technical regulatory improvements. Instead, it reflects a deeper strategic shift: Europe’s effort to build a faster, more digital, and more competitive clinical research environment.
The vision behind ACT EU is centred around creating more efficient, faster, and more modern clinical trials. Behind this direction lies a much broader transformation, as Europe seeks to redefine the way clinical studies are designed, approved, and implemented.
The New Competitive Advantage in Clinical Research
Europe increasingly recognizes that clinical research has become a field of intense global competition. ACT EU aims to increase multinational clinical trials while significantly accelerating approval procedures and study start-up timelines.
However, the real transformation is not only about speed. It is about the fact that clinical trials are now being treated as part of a broader digital health ecosystem.
Data is becoming central to this transition. ACT EU places strong emphasis on the use of data generated through clinical practice (real-world data), advanced data analytics, and digital tools throughout the entire clinical trial lifecycle. This clearly demonstrates that the future of clinical research will not be defined solely by pharmaceutical innovation, but also by the ability to manage, analyse, and effectively utilize data.
Artificial Intelligence Moves into Clinical Research
One of the most notable aspects of the new programme is the clear integration of artificial intelligence into Europe’s clinical trial ecosystem.
ACT EU includes initiatives and workshops focused on the use of AI in clinical trials, alongside the development of advanced data analysis tools. This is particularly important because it signals that AI is no longer viewed as a future concept, but as a practical tool for faster data analysis, improved study design, and more informed decision-making.
At the same time, Europe aims to ensure that AI adoption happens responsibly and within a robust regulatory framework. It is no coincidence that the programme directly connects innovation with regulatory science, participant protection, and trust in clinical trials.
Decentralised Clinical Trials and More Inclusive Research
ACT EU 2026–2027 also places significant emphasis on decentralised clinical trials and the integration of digital elements into research studies.
This shift is not only technological. It reflects a broader change in the philosophy of clinical research itself.
Decentralised approaches allow more patients to participate in clinical studies, including people living in remote areas, by reducing geographical and organisational barriers. At the same time, there is growing focus on making clinical research more inclusive, with stronger participation from underrepresented groups such as women, children, and people living with rare diseases.
The emphasis is gradually moving away from strictly hospital-centred trials toward more flexible and patient-centric models.
A New Ecosystem for Clinical Trials
Perhaps the most interesting aspect of ACT EU is that it goes beyond regulation alone. The programme systematically invests in building a new ecosystem for clinical trials.
Alongside regulatory reforms, strong emphasis is placed on education, support for academic institutions and SMEs, and the development of collaborative networks for sharing expertise, data, and clinical trial analytics tools.
The logic behind this approach is clear: innovation in clinical trials will not emerge solely from new therapies, but from collaboration between regulators, industry, researchers, healthcare providers, and technology stakeholders.
What This Means for the Greek Health Ecosystem
For Greece, ACT EU 2026–2027 creates both new opportunities and new requirements. Organisations active in healthcare, biotechnology, data, and AI are being called to operate in an environment where digital maturity becomes strategically important, data becomes a critical component of research and compliance, and collaboration gains greater value than isolated initiatives.
At the same time, the increasing emphasis on decentralised studies and digital tools opens the door for new services and innovative solutions in clinical research.
The Role of Health Hub
In this evolving environment, the role of Health Hub is to help healthcare organisations and businesses in Greece strategically leverage the European clinical research framework. As a European Digital Innovation Hub, Health Hub supports organisations active in digital health, data, and innovation to strengthen their digital maturity, develop collaborations, and benefit from European initiatives linked to clinical trials and health technologies.
More information about Health Hub’s services can be found here.