By Allison Proffitt 

October 22, 2025 | BARCELONA — European clinical research is at a critical crossroads, industry leaders warned last week at SCOPE Europe. Regulatory fragmentation, site readiness challenges, and prolonged approval timelines are driving sponsors to more competitive markets in Asia and the United States. 

The pharmaceutical executives painted a stark picture of Europe's declining competitiveness in the global clinical trial landscape, revealing that approximately 60,000 patients have been excluded from European trials in recent observation periods compared to previous years. 

Adama Ibrahim, EMBA, Vice President of Digital Transformation at Novo Nordisk's Research and Early Development division, didn't mince words when characterizing the current state of European clinical research. Ibrahim emphasized that the fundamental issue comes down to speed and predictability. 

"If sponsors can get the confidence that they can actually achieve their forecast and all their plans to the right time frame and also meeting the right costs and quality in all of those factors, then it's a no-brainer," Ibrahim said. "That's been challenging over the past 10 years." 

The decline in European clinical trials has been steady since 2013, predating the COVID-19 pandemic and coinciding with increased competitiveness from Asian markets, particularly China. 

Multiple Factors Behind the Decline 

Tero Laulajainen, Vice President and Head of Global Clinical Operations at UCB, identified patient access as the bottom-line issue driving location decisions. "China is today faster than Europe. The US has always been faster than Europe. But now Europe is even losing to China and huge access to patients," he said. 

Laulajainen pointed to several compounding factors: increasingly complex regulations, stretched healthcare systems, and sites struggling to participate under tremendous pressure. He highlighted contracting as a particularly significant hurdle, noting that industry averages show 180-day contracting timelines in major European countries. 

"When you try to facilitate that somehow and you come up with master service agreements with many institutions, what we realize is that the legal counsel at the institution changes and you start all over again," Laulajainen explained. 

Ibrahim added that protocol complexity has increased dramatically over the past decade, with more assessments, requirements, and complex data points. However, she noted that complexity alone doesn't explain Europe's competitiveness problem, as Asian countries manage similar protocols with faster timelines. 

Regulatory Fragmentation: The Core Challenge 

Both executives agreed that regulatory fragmentation across the European Union's 27 member states represents a fundamental obstacle to competitiveness. Despite aspirations for harmonization through initiatives like the Clinical Trials Regulation (CTR), reality often diverges from policy goals. 

"The regulatory fragmentation is almost ludicrous," Ibrahim said. "In this modern day and age, any other industry will not accept what we are accepting. How can a site or even a country have set up that takes six months? It just does not make sense! When you think about patients who are waiting for this therapy, six months is just unfathomable as far as I’m concerned.”  

She contrasted European timelines with other countries achieving one-month to eight-week setup times for the same studies, attributing delays to multi-layered approvals requiring sequential sign-offs from regulators, ethics committees, hospital R&D departments, and other bodies. 

Ibrahim questioned the lack of mutual recognition among regulatory authorities: "Why, in today's day and age, are we repeating checks? Why do we have such low trust within the regulatory set-up?" 

Bright Spots and Potential Solutions 

Despite the overall decline, Ibrahim and Laulajainen identified countries that have succeeded in bucking the trend. Denmark and Spain emerged as examples of member states that have accelerated timelines and improved competitiveness through concrete actions. 

"Countries actually do have a role and they can influence the ecosystem," Laulajainen said. "Whatever the EUCTR actually says, you can still influence the ecosystem in your country and be competitive." 

The UK also received recognition for recent initiatives, including the NHS 10-year plan and MHRA timeline reductions, though panelists noted these represent just initial steps. 

Ibrahim pointed to the need for political will and financial support, citing successful UK oncology programs where hospitals recruited 1,000 patients annually into clinical trials. "Without that political will, financial support, the right environment for things to thrive, whether it's from the regulatory end or translating into the hospitals, it's quite hard for one end to just be on their own," he said. 

The Infrastructure Gap 

Both executives emphasized that Europe's lack of modern digital infrastructure puts it at a disadvantage. Ibrahim highlighted difficulties in accessing feasibility data, real-world data, and patient identification tools compared to countries with integrated digital ecosystems. 

"If you don't modernize that, it is very, very difficult to be competitive with countries that have got digital ecosystems where they integrate all of the different relevant data points that you can use for meaningful insights to make those feasibility decisions," Ibrahim explained. 

Site Readiness: A Shared Responsibility 

When asked why industry doesn't simply invest more in site readiness, Ibrahim pushed back on the notion that pharmaceutical companies bear sole responsibility. 

"Is it the industry alone? I don't think so. I think it's the collaboration," she said, pointing to the UK's public healthcare system as an example where a purely commercial model is unrealistic. "Sites have to care for patients. That is the biggest challenge we have. Industry has to do research. The two can coexist." 

Laulajainen agreed that industry is willing to invest in site readiness but noted that location decisions ultimately depend on patient access and speed considerations. 

Europe's Competitive Advantages 

Despite the challenges, both panelists identified unique strengths that Europe could leverage to differentiate itself in the global clinical trial market. 

Laulajainen emphasized Europe's patient diversity as a significant advantage compared to more homogeneous populations in countries like China or Japan. Both executives also highlighted Europe's scientific excellence and technological capabilities. 

"We have some brilliant scientists in Europe and that is a competitive advantage. We have some brilliant technologies in Europe," Ibrahim said. "So I think the opportunity to be on the front end of innovation is the competitive advantage." 

Laulajainen suggested Europe should focus on areas where it excels: rare disease research, gene therapies, platform studies, novel modalities, and decentralized trials leveraging advanced technologies including artificial intelligence. 

The Path Forward 

Moderator Moe Alsumidaie, Chief Editor of Editorials at Clinical Trial Vanguard, framed the central question: "If the industry waits for regulators, [and] regulators wait for industry, Europe will continue to lose." 

Both Ibrahim and Laulajainen emphasized the need for collaboration among all stakeholders — regulators, industry, sites, and vendors — rather than waiting for any single entity to act first. 

Ibrahim suggested bringing sites to the table as partners, allowing them to vocalize their needs to both sponsors and regulators. Laulajainen pointed to industry feedback efforts, including the recent EFPIA survey, as evidence that pharmaceutical companies are actively working to influence the ecosystem. 

When asked what she would tell EMA's Chief Medical Officer in a one-minute conversation, Laulajainen said he would focus on patient impact: "I would go back to the numbers and talk about the number of patients that have missed the opportunity in participating in a clinical trial, the health benefits that Europe has lost in that, and the financial ramifications of what has happened." And if he was feeling a bit more provocative, he said, he’d ask: "What are you doing to increase patient value? We are trying really hard, and it feels like obstacles are being created." 

Ibrahim advocated for asking, “What does success look like for you? Is it bureaucratic? Or is it actually bums in seats?”  

Looking Ahead 

The European clinical trial community faces a critical moment. While the regulation aims to harmonize requirements across member states, concerns remain about localization requirements that could undermine standardization efforts. 

The session message was clear: Europe must act decisively to modernize infrastructure, streamline regulatory processes, and foster collaboration among all stakeholders. Countries like Denmark and Spain demonstrate that individual member states can improve competitiveness within the existing framework, but broader systemic change will require political will, financial investment, and a commitment to placing patient access at the center of clinical research policy. 

Without such action, Europe risks falling further behind in the race to bring innovative therapies to patients who need them most.