European Oncology Clinical Trials: Site Selection Beyond Traditional Markets
Europe continues to play a critical role in global oncology drug development. For sponsors expanding oncology clinical trials into Europe, the region offers experienced investigators, well-established cancer centers, diverse patient populations and increasingly harmonized regulatory pathways. Yet selecting where to conduct a clinical trial is becoming more complex.
The implementation of the European Clinical Trials Regulation (CTR), evolving diagnostic requirements under the In Vitro Diagnostic Regulation (IVDR), growing competition among research sites and changes in regional clinical trial activity are reshaping how sponsors evaluate clinical trial feasibility across Europe. Simultaneously, many of the public data sources used to understand these trends remain fragmented, making it difficult to develop a complete picture of the European clinical trial landscape. Research being presented at the 2026 European Society for Medical Oncology (ESMO) annual meeting explores how publicly available clinical trial data can be used to better understand oncology clinical trial activity across Europe, and how those insights may help sponsors make more informed feasibility and site selection decisions.
Explore how Syneos Health helps sponsors navigate European clinical development, site selection and operational strategy.
Europe Remains a Strategic Region for Oncology Drug Development
For decades, countries such as Spain, Italy, Germany and France have served as important locations for oncology clinical research. Strong investigator networks, experienced study sites and established regulatory processes have made these markets attractive for sponsors conducting early and late-phase oncology trials. More recently, however, the European clinical research environment has continued to evolve.
Implementation of CTR has introduced greater regulatory harmonization across European Union member states, while IVDR has created additional considerations for biomarker-driven and precision oncology studies. Together, these changes raise important questions about how sponsors evaluate country selection and whether historical assumptions about the European clinical trial landscape continue to reflect today's development environment.
Understanding Clinical Trial Activity Across Europe Is More Challenging Than Expected
One of the most significant findings from this research was the difficulty of measuring trends in oncology clinical development. Although multiple public databases provide information on European clinical trials, each captures different aspects of the research landscape.
ClinicalTrials.gov includes both EU and non-EU countries, making it useful for regional comparisons, but may not accurately reflect ex-US clinical trial activity. The Clinical Trials Information System (CTIS) reflects Europe's newer regulatory framework but contains different data structures and reporting approaches. Legacy studies remain distributed across older databases, making longitudinal analyses particularly challenging. These differences create practical challenges for sponsors attempting to evaluate clinical trial activity across Europe using publicly available information alone.
Looking Beyond Traditional European Trial Hubs for Oncology Clinical Trials
The analysis examined oncology clinical trial activity across Europe over approximately five years while adjusting findings for population size and estimated research workload. As expected, established countries such as Spain remained among the most active regions for oncology clinical development. Spain's longstanding investment in early phase oncology research, centralized healthcare system and experienced investigator networks continue to make it one of Europe's most active clinical trial environments.
However, adjusting for population size also highlighted an important observation. Several European countries with experienced investigators and established oncology capabilities continue to see comparatively less sponsor activity than traditional trial hubs. These findings do not necessarily indicate that these countries are underutilized from an operational perspective, nor do they suggest sponsors should immediately alter site selection strategies. Rather, they raise important questions about how historical sponsor preferences, operational considerations and available data collectively influence where oncology studies are conducted and may indicate juristictions available for more clinical research activity.
Clinical Trial Site Selection Requires More Than Historical Experience in Europe
Country selection has always relied on multiple factors, including investigator expertise, regulatory timelines, operational readiness, patient availability and prior sponsor experience Public data should complement those considerations.
Analyses such as these are intended to generate hypotheses that deserve further evaluation. If a country consistently demonstrates lower levels of sponsor activity, does that reflect operational challenges, limited capacity or simply fewer historical development programs? Conversely, if a small number of countries continue attracting the majority of studies, are there opportunities to broaden the clinical trial footprint while maintaining quality and operational efficiency?
These questions become increasingly important as oncology studies grow more complex and competition for experienced research sites continues to increase. For sponsors, the opportunity is not necessarily to move away from established markets, but to periodically reassess long-standing feasibility assumptions as regulatory frameworks, diagnostic requirements and research activity continue to evolve.
Better Data Can Support Better Clinical Development Decisions in Oncology Clinical Trials
The research also highlighted broader opportunities to improve publicly available clinical trial data. Differences in disease classification, patient segmentation and trial reporting make large-scale analyses considerably more difficult than they need to be. Similar oncology populations are often categorized differently across databases, with sometimes inaccurate algorithmically-driven classification of key parameters. Important information may be readily available in one system but absent from another.
Greater standardization and established processes for data mining (e.g., API access) would support more robust clinical trial feasibility assessments, improve competitive intelligence, strengthen site selection analyses and help patients identify clinical trials more effectively. As precision oncology continues to define increasingly specific patient populations, structured and interoperable data will become even more valuable for sponsors planning future development programs.
Looking Ahead in European Oncology Clinical Trials
Expanding oncology clinical trials into Europe requires balancing scientific, operational and regulatory considerations across an increasingly dynamic landscape.
While regulatory harmonization continues to improve opportunities for sponsors throughout Europe successful clinical trial site selection will depend on combining operational expertise with high-quality data and local market knowledge.
This research demonstrates that publicly available data can provide valuable insights into Europe's evolving oncology clinical trial landscape, but it also underscores the importance of understanding the limitations of those data. As sponsors continue evaluating opportunities across both established and emerging European markets, improving how clinical trial information is collected, structured and analyzed may become just as important as the trends the data reveal themselves.
See how Syneos Health supports oncology sponsors with clinical development, feasibility, site selection and execution across Europe.
Contributors
Senior Medical Director, Medical Management
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