Regulatory and organisational barriers to non-commercial clinical trials in European nuclear medicine: Results from an EANM survey

ABSTRACT Background Non-Commercial Clinical Trials (NCCT) are essential for generating independent evidence in nuclear medicine. However, European clinical investigators face persistent barriers to trial initiation and conduct. This study aimed to identify and characterise the main obstacles for NCCT in nuclear medicine across Europe. Methods A 15-item online survey was designed by the EANM ACT EU Project Group and disseminated to nuclear medicine professionals between October and December 2025. The survey covered respondent profile, prior trial experience, perceived barriers, critical steps, patient-related limitations, and proposed solutions. Quantitative data were analysed descriptively; open-ended responses were manually reviewed and grouped into recurring themes. Results Ninety-two responses were received; after exclusion of three non-European responses, 89 respondents from European countries were included in the main analysis. Overall, 65% of respondents were nuclear medicine physicians, 71% had more than 10 years of experience, and 82% reported prior trial involvement. Regulatory complexity (67%), lack of funding (51%), and administrative burden (36%) were the top barriers. Ethical/regulatory approval was the most critical trial step (49%). Cross-country regulatory differences were considered the main obstacle to multicentre trials by 78% of respondents. The most endorsed solutions were a harmonised regulatory framework (69%), dedicated funding programmes (62%), and shared infrastructure platforms (37%). A European-level harmonised approval pathway for radiopharmaceutical clinical trials was considered important by 99% of respondents. Conclusions NCCT in European nuclear medicine are primarily limited by regulatory fragmentation and organisational constraints rather than scientific feasibility. EU-level regulatory harmonisation, dedicated funding, and shared infrastructures are identified as key enablers for academic trial development.