Building a Smarter European Country Strategy for Your Next Oncology Study: Four Strategic Considerations
When developing a country strategy for an oncology trial in Europe, sponsors must weigh a wide range of scientific, operational, regulatory, and financial considerations. While every study is different, certain factors consistently influence how efficiently a trial starts, enrolls, and progresses.
Some of these considerations—such as regulatory timelines and patient population estimates—are well established. Others receive less attention during planning, despite having a meaningful impact on study execution and enrollment performance.
Below are four often under-considered factors that can help sponsors build a smarter European oncology country strategy.
1. Understanding Local Standard of Care and Treatment Pathways
Standard of care is different depending on country, and unfortunately, in many Eastern European countries, access to newer oncology treatments can be limited. As a result, patients with the same diagnosis may be eligible for a study in one country but not another because they have progressed through different treatment pathways.
In these programs, understanding local biomarker testing practices and treatment sequencing is often more important than understanding disease prevalence alone.
2. The True Cost of Enrollment: Reimbursement
In oncology studies, enrollment economics can be heavily influenced by whether the standard-of-care therapy is reimbursed. Depending on the country, sponsors may be required to pay for therapies that would otherwise be considered standard of care. As a result, two countries with similar enrollment potential may have very different cost profiles.
It’s also important to note that investigator grants and site fees are typically lower in Europe than in the U.S. This can offset the cost of reimbursement fees.
3. CTIS Has Harmonized Regulatory Submissions—Not Country-Level Execution
The implementation of the Clinical Trials Regulation (CTR) and Clinical Trials Information System (CTIS) has transformed the European regulatory landscape.
Sponsors now benefit from a centralized submission process, coordinated assessments, and defined review timelines that provide greater predictability than the historical model. However, regulatory harmonization should not be confused with operational harmonization.
Each country continues to maintain its own processes that can influence startup timelines and study execution. For example, France has specific procedures related to site payments and patient reimbursement. Italy requires investigators participating in Phase I studies to hold the appropriate accreditation, which can influence site selection. In Poland, sponsors may encounter multiple contracts and budget negotiations at a single site.
A Note About Choosing the Right RMS
A key strategic decision within the CTR process is the selection of the Reporting Member State (RMS). While CTIS has harmonized the overall review framework, the experience can still vary depending on which authority leads the assessment.
Some RMSs—Spain, for example—are known for conducting efficient, pragmatic reviews and providing focused feedback, while others may take a more detailed approach, resulting in a higher volume of feedback and/or questions.
4. Site Selection vs Country Selection
Enrollment performance is ultimately driven by sites, not countries. Europe is known for its high-performing oncology centers with established referral networks, experienced research teams, and a proven track record of enrollment. As a result, country selection should not be viewed independently from site selection. A high-performing site may be located in a country with more extensive startup requirements, but the enrollment benefits can often outweigh the additional upfront effort. Sponsors should rely on the expertise of local CROs to understand which sites can deliver for their protocols.
The Best European Strategy Is a Local Strategy
One of Europe’s greatest strengths is the diversity of its healthcare systems, but that diversity also means successful country selection requires a more nuanced approach. Sponsors that understand how treatment pathways, operational requirements, and study economics vary across Europe are better positioned to build effective country strategies and bring high-performing sites online efficiently, even when navigating country-specific requirements.
