Recommendations on cross-border access to clinical trials

EU X CT recommendations focus on making cross border participation in clinical trials a safe, practical and realistic option for patients in Europe, especially when no appropriate trial is available in their home country. They were developed by the EU X CT multi stakeholder initiative, co led by the European Forum for Good Clinical Practice (EFGCP) and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Draft recommendations were made publicly available in early 2025 for consultation and then consolidated with input from more than 100 experts and stakeholders from patient organisations, academia, clinical research networks, regulatory authorities and industry. It is a guideline‑type resource, supported by online tools (trial preparator and a small country profile database).

The website provides a consolidated overview of regulatory, ethical, legal, financial and logistical issues to consider when accepting cross border participants. It offers practical guidance for:

• Trial design and feasibility planning for cross border enrolment.
• Site readiness, including processes for travel, accommodation, insurance and continuity of care.
• Operational pathways for follow up when patients return to their home country.
• Helps researchers understand the perspectives of patient organisations, payers and other stakeholders, supporting protocol design, feasibility assessments and clear patient information materials.
• Encourages more consistent approaches across sites and countries, helping to reduce administrative barriers and uncertainty around cross border enrolment.

The EU X CT website is organised for two main user groups:

1. Patients and caregivers
2. Clinical trial professionals

Shared resources for both groups include the EU X CT recommendations on cross border access to clinical trials and the 2025 Public Stakeholder Conference report.

Section for Patients and Caregivers:

• Patient and caregiver stories that illustrate real life experiences of seeking a trial abroad.
• A practical information section for patients and caregivers explaining key issues to consider when thinking about cross border trial participation.
• A trial preparator that supports people who have already identified a potential trial outside their own country by:
• Highlighting what information to gather and what questions to ask.
• Helping them prepare discussions with their treating physician and the trial team.
• Providing links to the EU Clinical Trials Map and ClinicalTrials.gov so users can explore ongoing studies.
  Section for Clinical Trial Professionals
• Access to the same recommendations and 2025 conference report to inform protocol design, feasibility and site processes.
• Country profiles for selected European states, with preliminary information (for both directions: patients going abroad and patients coming from abroad to the trial country) on legal, organisational and practical conditions for cross border participation.
• Country profiles are currently available for: Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Poland, Portugal and Spain. The country information is preliminary and will be continuously updated as more data become available.