On International Clinical Trials Day, we’re reminded of the vital, transformative role clinical research plays in advancing medicine. Every treatment we rely on today started as an idea tested and refined through clinical trials.
Yet, for patients in Central and Eastern Europe, systemic barriers often stand in the way of accessing studies. Language obstacles, financial challenges, regulatory complexities, and logistical hurdles create inequities that exclude many who are willing and eligible to participate.
This blog examines those barriers, explores solutions to address them, and shines a light on initiatives like EU-X-CT, which aim to break down these divides. Collaboration is the key to creating a system where clinical trials are accessible to all, regardless of geography.
The hurdles faced by many Central and Eastern European (CEE) patients are varied and numerous. Camelia Isaic, a Czech Republic-based rare disease advocate and patient, shared her experience with the patient challenges of accessing clinical trials in other EU countries.
"The language barrier is a significant obstacle to start with. While some patients are fluent in English, although it is not their native language, it still is problematic for them to be considered as eligible in countries where English is not the official language, as most documents, including informed consent forms, are only approved in the local language. Receiving approval to participate using English documentation is bureaucratic and not possible to attain for all interested patients,” Camelia shared.
Beyond the language barriers, financial strain can place a significant burden on clinical trial participants. While some sponsors outsource travel and accommodation costs for site visits to specialized agencies, ensuring more seamless logistics, others require patients and their families to cover these expenses upfront, often offering reimbursement on a six-month cycle. This approach can result in patients accumulating substantial debt, with personal funds being tied up or credit card limits exceeded, severely impacting their financial liquidity.
For cross-border participants, navigating home-country health insurance can add another layer of complexity, particularly for those receiving placebos. This can leave patients feeling trapped within conflicting systems, adding financial and emotional distress to an already challenging experience.
Across smaller European countries, patients encounter barriers such as unclear communication about clinical trial availability, difficulties to enroll even for an initial screening visit and the overwhelming financial risks. Additionally, the lack of patient-support infrastructure forces participants to manage complex and unfamiliar processes on their own.
For many, these barriers are insurmountable. Patients often abandon their efforts altogether, not because they lack the will to participate, but because the system is not designed for them.
Many clinical trial materials are offered exclusively in the host country's language, without accounting for cross-border participants. This leaves non-native speakers at a disadvantage, often excluding them unless they can advocate for themselves. However, many patients lack the resources or ability to take on this challenge. Multilingual trial designs are essential to promote inclusivity and equitable access.
Cross-border clinical trials often come with hidden costs, such as travel, accommodations, and even out-of-pocket expenses for emergency care during adverse events. Without adequate financial support, these challenges disproportionately affect patients from diverse financial backgrounds, further reinforcing access inequities. Camelia captured the issue well, stating, “Some patients give up because they need upfront funds for travel or face reimbursement delays that last months. It’s an impossible situation for many families.”
Insurance coverage for cross-border care is unreliable and inconsistent. Patients are often left uncertain about what costs will be reimbursed while having to arrange travel and coordinate care on their own. For patients with rare diseases in smaller countries, these logistical hurdles create barriers that are nearly impossible to overcome.
Addressing these systemic barriers calls for streamlined solutions that acknowledge patient diversity and provide robust logistical and financial support, ensuring cross-border clinical trials become accessible for all.
Achieving meaningful progress in clinical research relies heavily on cross-border collaboration. This is particularly crucial for rare disease trials, which depend on accessing internationally dispersed patient populations to reach significant and comprehensive outcomes. However, past structural challenges within Europe have hindered this potential.
The EU-X-CT initiative seeks to overcome these barriers. By incorporating insights from patients, sponsors, investigators, and policymakers, this multi-stakeholder project is shaping recommendations that could serve as the foundation for more inclusive clinical trial policies.
Also a member of this initiative, Camelia emphasized the significance of this work. “Through EU-X-CT, we are working to establish a shared framework for cross-border trials, addressing everything from insurance gaps to logistical coordination. For patients, this could mean far fewer barriers when seeking participation outside their home countries.”
With a second public stakeholder meeting planned for June 24th in Brussels, the initiative is poised to take another step toward actionable solutions. Scout’s expertise in patient navigation services stands to provide valuable perspectives and contributions to this vital work.
Cross-border trials also raise ethical considerations. Patients from countries with limited healthcare options often participate in experimental treatments without access to basic safety nets. Balancing the promise of new treatments with the ethical responsibility to protect patient welfare is a pressing challenge.
“As sponsors and stakeholders, we must ask hard questions,” said KimberLee Heidmann, Scout’s Executive Vice President, Quality and Regulatory, and Data Protection Officer. “Are we acting in patients’ best interests when balancing ethical concerns with the business goals of clinical trials? This is the kind of discussion our industry needs to have more often.”
Patient navigation programs are essential in bridging gaps in access. These services offer practical support by coordinating travel, assisting with visas, and managing financial challenges so patients can focus on their health.
Scout is at the forefront of these efforts, offering hands-on support that ranges from multilingual communication to pre-funding travel expenses. Through its collaborative partnership with myTomorrows, Scout also facilitates patient pre-screening and trial matching, further strengthening the ability to connect oncological patients with lifesaving opportunities.
Camelia emphasized the importance of these programs. “The idea of patient navigation services is a minimum need, not a luxury, to enhance cross-border access to clinical trials in Europe and beyond. Having someone local or familiar to guide patients would bring so much comfort to patient families.”
Making clinical trials more inclusive requires real action from all stakeholders.
Beyond fairness alone, representation in clinical trials is about generating better-quality data and driving scientific breakthroughs that benefit everyone. Barriers in accessibility don’t only delay advancements in medicine; they can cost lives.
Inclusive trials require collaboration between sponsors, governments, and advocacy organizations. By addressing accessibility gaps with real commitments and shared accountability, we can achieve a future where all patients, regardless of geography or socioeconomic status, can access life-changing treatments.
Camelia’s insights remind us how much work remains. This International Clinical Trials Day, take action. Whether it’s advocating for policy change, supporting underserved regions, or partnering with organizations like Scout, our efforts can create a ripple effect of progress.
Camelia Isaic is chairwoman and co-founder of HAE Junior, a Czech patient organization whose mission is to improve the quality of life of children & adolescents with hereditary angioedema (HAE). She is also a member of the RIPAG patient council, which is part of the ERN-RITA – European Reference Network for Rare Immune Disorders and a team member of the multi-stakeholder EU-X-CT Initiative on Cross-Border Access to Clinical Trials.