Europe’s Clinical Trial Exodus: Can the Region Regain Its Competitive Edge?

At the SCOPE 2025 Europe conference, during a panel titled, “Trials Are Leaving Europe — Can We Bring Them Back?”, industry leaders Tero Laulajainen, VP and Global Head of Clinical Operations at UCB, and Adama Ibrahim, former VP of R&ED Digital Transformation at Novo Nordisk, joined Clinical Trial Vanguard’s editor Moe Alsumidaie to confront an uncomfortable reality: Europe’s share of global clinical trials has fallen sharply over the past decade. The panel dissected the data, debated the causes, and explored the pathways to restoring Europe’s competitiveness in research—a topic increasingly prioritized by the European Medicines Agency (EMA).

A Shrinking Footprint: Understanding the Decline

The discussion began with figures from an EFPIA report showing that Europe’s share of global clinical trials has dropped precipitously since 2013. The European Economic Area’s portion fell from roughly 18% to 9%, while commercial studies declined from 22% to 12%. Phase 1 trials—the entry point for early innovation—have been particularly affected, signaling waning competitiveness at the foundational stages of drug development.

Panelists attributed the decline to a constellation of interrelated factors: regulatory fragmentation, growing protocol complexity, sluggish study start-up timelines, and stretched healthcare infrastructure. Europe’s slow approvals were contrasted with Asia’s agility, where single-country trials can progress rapidly despite similar scientific and operational complexities.

“Speed and predictability,” the panel noted, have become decisive criteria for sponsors. Delays of six months or more in multi-country approvals render Europe less attractive compared to China—now faster than Europe—and the U.S., which continues to dominate global trial activity.

Systemic Barriers: Fragmentation and Bureaucracy

The panel identified regulatory fragmentation across 27 member states as a key structural obstacle. Despite aspirations for harmonization under the Clinical Trials Regulation (CTR), each member state retains unique approval layers—ethics committees, hospital R&D departments, and localized documentation—creating bottlenecks that can double or triple activation timelines compared to other regions.

Ibrahim characterized the situation as “almost ludicrous” for a modernized industry, noting that setup times of six months in some European hospitals starkly contrast with one-to-two month averages elsewhere. Laulajainen added that site contracting alone can take 180 days on average in major European markets, often requiring a restart from scratch when institutional legal counsel changes.

Both experts underscored the resulting inefficiency: duplicated reviews, inconsistent trust among regulators, and missed opportunities for collaboration. The lack of mutual recognition—where one national approval could streamline others—was cited as emblematic of Europe’s bureaucratic inertia.

Case Studies: When Modernization Works

Despite the overall decline, select countries have defied the trend. Denmark and Spain were highlighted as models of modernization, having invested in integrated digital infrastructures that facilitate faster patient identification, data interoperability, and centralized feasibility assessment.

Denmark’s national health data architecture enables near-real-time recruitment insights, while Spain’s public investment in oncology research has yielded recruitment rates exceeding 1,000 patients annually per hospital during its peak programs. These examples illustrate that success hinges not on cost reduction but on speed, data connectivity, and coordinated political will.

“Identifying patients requires data,” Ibrahim emphasized, citing digital readiness as the foundational barrier. Countries lacking integrated electronic health records or national feasibility registries are at a structural disadvantage in attracting multinational trials.

The Politics of Progress

While regulatory harmonization remains elusive, both panelists argued that national political will—and not supranational reform—is the true lever of change. Public investment, as seen in the UK’s 10-Year Plan and MHRA’s timeline reduction initiatives, can catalyze research competitiveness even within constrained public budgets.

The UK’s experience in oncology trials was described as a “golden moment” driven by direct ministerial support, leading to dramatic gains in recruitment and site participation. The takeaway: political alignment between ministries of health, regulators, and hospitals can overcome even entrenched bureaucratic complexity.

Laulajainen stressed that countries must recognize clinical research as an economic engine, not merely a regulatory burden. He noted that Spain’s government quantified the monetary value of hosting trials—spurring sustained policy support and signaling to investors that clinical research is a national asset.

The Industry’s Role: Collaboration, Not Complacency

When asked whether the burden of reform rests with regulators or sponsors, both speakers agreed that industry influence remains significant. Pharmaceutical companies, CROs, and technology providers can reshape local ecosystems by investing in site readiness, digital enablement, and shared data infrastructure.

Ibrahim emphasized a “bottom-up” approach, encouraging sites to act as vocal partners rather than passive participants. Sites, she said, should articulate their needs—staffing, training, data support—to sponsors and regulators to ensure mutual alignment.

Laulajainen added that while global sponsors are willing to invest in site readiness, they must prioritize geographies where patient access is feasible. “If speed is the currency,” he said, “investment follows the markets that can deliver.”

Both underscored the need for research to integrate seamlessly into clinical care rather than compete with it. Building trials into existing healthcare workflows, supported by digital scheduling and reimbursement systems, was cited as essential for sustainable readiness.

New Models for European Leadership

The final segment shifted from diagnosing decline to identifying Europe’s potential to redefine its role through next-generation trial models. Panelists argued that Europe’s strength lies not in competing on volume or speed alone but in leveraging its scientific depth, technological talent, and patient diversity.

They envisioned Europe as a hub for:

• Rare disease and gene therapy studies, where scientific complexity outweighs speed.

• AI-enabled and digital-first trials, supported by Europe’s strong privacy and cybersecurity frameworks.

• Decentralized and hybrid models, aligning with the region’s push toward patient-centricity and remote monitoring.

• Diversity-driven research, capitalizing on the continent’s heterogeneous population to strengthen external validity of data.

Ibrahim called for greater integration of artificial intelligence and automation in feasibility and data management, noting that Europe’s “brilliant scientists and technologists” are underutilized. She framed innovation not as a luxury but as Europe’s path to differentiation in an era where Asia increasingly dominates traditional trial models.

Outlook: From Excuse to Opportunity

In closing, Alsumidaie summarized the discussion with a challenge to the industry: fragmentation, while real, must not become an excuse for inaction. Whether driven by EMA reforms, national initiatives, or industry innovation, change will require collaboration across all fronts.

The panelists concurred that Europe’s decline is reversible—but only if stakeholders treat the crisis as a catalyst for reinvention rather than resignation. “The question,” Alsumidaie concluded, “is whether fragmentation becomes our excuse—or our reason to innovate a European model for the next era of clinical trials.”