A clinical research industry blog

The Perfect Storm Challenging European Clinical Trials

Written by Graham Belgrave, Managing Director, International | 9/10/26, 8:00 AM

Europe’s clinical research sector finds itself at a defining moment. A convergence of economic, geopolitical, regulatory, and operational pressures is undoubtedly creating significant challenges for clinical trial delivery and the broader life sciences industry. Yet amid these headwinds lies a less frequently discussed reality: Europe also possesses many of the ingredients needed to emerge as a global leader in the next era of scientific and clinical innovation.

 

 

 

The concerns highlighted by Thomas Senderovitz, CEO of the Danish Association of the Pharmaceutical Industry, at the recent PCMG Conference in Berlin should be taken seriously. Clinical trial activity in Europe is declining, investment patterns are shifting, and global competition is intensifying[1]. However, viewed through a broader lens, these developments should not be interpreted solely as evidence of decline. Rather, they reveal a continent at a strategic crossroads, facing both significant risks and potentially unprecedented opportunities.

The stakes are considerable. The pharmaceutical industry remains one of Europe’s most important strategic sectors, contributing substantially to economic growth, exports, employment, healthcare innovation, and research investment[1][2]. Europe continues to generate world-leading science and remains home to globally respected universities, research institutes, healthcare systems, and regulatory agencies. Yet maintaining scientific excellence is no longer sufficient. The challenge increasingly lies in translating that excellence into innovation, investment, clinical development, and patient benefit.


One of the most visible indicators of Europe’s challenges is the decline in its share of global clinical trial activity. Data presented by Senderovitz showed that Europe is steadily losing ground while China has overtaken Europe in the proportion of globally initiated clinical trials[1]. This trend reflects broader changes in how sponsors evaluate investment decisions. Clinical trial placement is increasingly driven by speed, predictability, recruitment capability, operational efficiency, and access to patients. Sponsors today are seeking environments that can accelerate development timelines while maintaining quality and regulatory compliance.


From a clinical study delivery perspective, this shift should not be viewed solely as a competitive threat from China or the United States. It should also prompt critical self-reflection regarding the complexity of the European research environment. Despite substantial strengths, sponsors frequently encounter fragmented healthcare systems, lengthy contracting processes, variable site activation timelines, and differing national requirements. Collectively, these factors create friction that can diminish Europe’s attractiveness as a destination for clinical research investment[3][4].


Yet focusing exclusively on these weaknesses risks overlooking Europe’s considerable strengths. As highlighted in a recent Nature analysis, Europe remains one of the world’s foremost scientific regions, producing more scientific publications than the United States and maintaining exceptionally high levels of international collaboration[5]. European researchers continue to contribute disproportionately to many of the world’s most influential scientific discoveries, while institutions such as CERN, the European Molecular Biology Laboratory, and leading academic medical centres remain global benchmarks for scientific excellence[5].


The problem, therefore, is not a lack of science.


The greater challenge is Europe’s ability to convert scientific excellence into commercial innovation, industrial growth, and healthcare impact. The Nature analysis highlights what many policymakers now describe as Europe’s “innovation translation gap”[5]. While Europe produces world-class research, it has often struggled to generate the same level of venture capital investment, technology scale-up, and industrialisation seen in the United States and increasingly in China[5][6]. Industry performs approximately two-thirds of European R&D activity, compared with more than three-quarters in both China and the United States, illustrating a structural weakness in transforming research into economic value[5].


The implications for clinical research are profound. Clinical trials sit at the intersection of science, healthcare, regulation, and commercialisation. When innovation ecosystems weaken, clinical development activity often follows. Senderovitz highlighted a concerning negative spiral in which fewer product launches lead to fewer clinical trials, reduced R&D investment, lower manufacturing investment, fewer high-value jobs, and ultimately diminished patient access to innovation[1]. Recent analyses suggest that Europe is already experiencing elements of this cycle, with increasing delays in patient access to new medicines and a declining share of global pharmaceutical investment[7].


The geopolitical environment further complicates the picture. Europe faces growing competition for life science investment from both the United States and Asia, while ongoing concerns about supply-chain resilience, economic security, and strategic autonomy continue to shape policymaking[6]. The COVID-19 pandemic exposed Europe’s dependence on external manufacturing capacity for many critical medicines and active pharmaceutical ingredients, reinforcing the importance of maintaining a robust domestic life sciences sector.


Yet geopolitical disruption also delivers opportunities.


The Nature article argues that Europe may be entering a unique period in which global scientific talent, investment, and collaboration are being reshaped by broader geopolitical developments[5]. Initiatives such as the European Union’s “Choose Europe” programme, combined with proposed increases in Horizon Europe funding, signal a growing ambition to position Europe as a global scientific hub capable of attracting leading researchers and innovators from around the world[5].


For clinical research, talent remains one of the most important determinants of future competitiveness. The ability to attract outstanding investigators, data scientists, clinicians, biostatisticians, and technology innovators may prove as important as any regulatory reform. Europe already possesses many of the cultural and institutional advantages that researchers value, including international collaboration, scientific freedom, strong public research infrastructure, and long-term commitment to evidence-based policymaking[5].


Encouragingly, Europe is not standing still. The implementation of the Clinical Trials Regulation (CTR), the Clinical Trials Information System (CTIS), and the Accelerating Clinical Trials in the European Union (ACT EU) initiative represent important steps towards improving the efficiency and attractiveness of European clinical research[3][4][8]. These initiatives aim to simplify trial approvals, enhance harmonisation across Member States, strengthen collaboration, and reduce unnecessary administrative burden.


However, regulatory reform alone will not be sufficient.


The future competitiveness of European clinical research will depend upon creating an integrated innovation ecosystem that extends well beyond the clinical trial process itself. This means strengthening health data infrastructure, embracing artificial intelligence and advanced analytics, supporting decentralised and point-of-care trial models, enabling researcher mobility, improving access to risk capital, fostering industry-academic partnerships, and creating pathways that allow innovative companies to scale successfully within Europe[4][5][6].


Equally important is investment in operational capability. Sustainable site networks, digitally enabled investigators, highly skilled clinical research professionals, and engaged patient communities will remain fundamental to successful study delivery. Technology can accelerate execution, but trust, expertise, collaboration, and patient-centred design remain the cornerstones of high-performing clinical research.


As leaders in clinical study delivery, we must recognise that clinical trials are more than operational activities. They are indicators of innovation health, drivers of economic growth, and mechanisms through which scientific discovery becomes patient benefit. When trials move elsewhere, expertise, investment, and opportunities often follow.


The perfect storm facing European clinical trials is therefore real. Declining trial activity, increasing competition, investment pressures, and geopolitical uncertainty all require urgent attention. Yet Europe also possesses extraordinary scientific assets, a deeply collaborative research culture, world-class healthcare systems, and a growing commitment to strengthening research and innovation.


The challenge is no longer simply preserving competitiveness. It is converting scientific excellence into sustained innovation leadership.


If Europe can align research policy, clinical development, investment, talent, regulation, and industrial strategy around a common vision, it has the potential not merely to recover lost ground but to emerge as a global leader in the next generation of life science innovation[5][6].


The window of opportunity remains open. The question is whether Europe can move quickly enough to seize it.

References
  1. Senderovitz T. Life Science Industry in Stormy Times. Presentation delivered at the PCMG Conference, Berlin; 2026.
  2. European Federation of Pharmaceutical Industries and Associations (EFPIA). The Pharmaceutical Industry in Figures 2025. Brussels: EFPIA; 2025.
  3. European Medicines Agency. Clinical Trials Regulation (EU No 536/2014). Amsterdam: EMA; 2025.
  4. European Medicines Agency. Accelerating Clinical Trials in the European Union (ACT EU).
  5. Gibney E. Europe’s science superpower ambitions. Nature. 2026;654:856–859.
  6. Draghi M. The Future of European Competitiveness. Brussels: European Commission; 2024.
  7. European patient access to new drugs worsens, pharma lobby says. Reuters. 2026 Jun 22.
  8. Schindler T. Fear of CTIS – Relocation of Phase 1 trials from Europe? Presentation delivered at the EFGCP Conference 2026.