Lääkevalmisteiden kliinisten tutkimusten rajat ylittävä saavutettavuus Euroopan unionissa

Clinical trials are essential for the development of new medicines and treatment methods, providing the evidence required to evaluate their safety, efficacy and quality before they can be introduced into clinical practice. As clinical research has become increasingly international, cross-border participation in clinical trials has gained growing importance within the European Union, particularly in the context of rare diseases where patient populations are often small and geographically dispersed. To facilitate multinational clinical research, the European Union has implemented several regulatory reforms, including the Clinical Trials Regulation (EU) No 536/2014 and the Clinical Trials Information System (CTIS), which aim to harmonize authorization procedures, improve transparency and strengthen Europe's competitiveness in global clinical research. Despite these developments, cross-border clinical trials continue to face practical challenges related to differences in national healthcare systems, ethical review processes, reimbursement policies, insurance requirements, administrative procedures and language barriers. The Nordic countries provide a particularly relevant setting for cross-border clinical research due to their similar healthcare systems, collaborative networks and cooperation. Existing Nordic collaborations in fields such as pediatric oncology, hematology and rare diseases demonstrate the potential benefits of regional cooperation in improving patient access to innovative therapies and specialized clinical trials. The aim of this study was to investigate the accessibility of cross-border clinical drug trials within the European Union, with also focusing on the Nordic countries, through semi-structured expert interviews. Experts representing different stakeholder groups involved in clinical research were interviewed to explore their experiences, perceptions and perspectives regarding the practical implementation of cross-border clinical trials. The interviews focused on identifying current barriers, existing facilitators and future opportunities for improving patient access to multinational clinical research. The interview data were analyzed using qualitative thematic analysis to identify recurring themes across participants. The study identified several factors influencing the implementation of cross-border clinical trials. Key barriers included differences in national regulations and practices, administrative burden, funding-related challenges, and varying levels of readiness among research networks. Factors facilitating cross-border clinical research included effective international collaboration, more harmonized procedures, the use of digital solutions and the development of patient-centred practices. In addition, the study identified several areas for further development that were considered essential for improving equitable patient access to clinical trials and strengthening cross-border clinical research within the European Union.