S1427
Interdisciplinary - Health economics & health services research
ESTRO 2026
identified and presented in a study framework including the following aspects: study design, quality standards, patient involvement, health economics, study management and organization, and relation to other studies. The focus was on key design components relevant to multicenter studies in the radiotherapy field. Results: A study framework encompassing key challenges and opportunities was identified during the planning, setup and conduction of the PROTECT trial (Figure 1). Key challenges included substantial international variation in clinical and radiotherapy practice necessitating expert collaboration. The study protocol and radiotherapy quality assurance (RTQA) writing groups included eight centers focusing on pragmatic yet high-quality requirements feasible for centers involved. Regular meetings from December 2019 facilitated consensus on study protocol, target definition, and RTQA, as previously described [1,2,3,4]. An application for the EU IMI Horizon 2020 call was prepared involving esophageal cancer specialists from eight countries. Regulatory and legal barriers, and inter-center differences necessitated the recruitment of a dedicated project manager in 2021 to finalize agreements, liaise with EU, and study coordination. During study conduct, patient recruitment was challenged by differences in referral patterns, insurance policy requirements, and changes in standard of care. To address this, novel solutions were developed to engage countries unable to participate in the randomized trial while still using the same treatment strategy, added a dedicated health economics work package, extensive patient and public involvement and engagement activities, as well as updating the trial design and sample size. The above- mentioned initiatives were executed by eleven work packages in the PROTECT trial consortium, each focused on key elements, and collectively ensuring robust trial conduct and enhanced international collaboration (Figure 2).
Conclusion: This study identifies key components essential for the planning, setup, and delivery of international radiotherapy trials, using the PROTECT trial as model. The framework provides actionable insights for future multicenter research, addressing common challenges and optimizing trial quality and collaboration. References: 1, Mortensen HR et al. Radiother Oncol. 2024;190:109980. doi: 10.1016/j.radonc.2023.109980.2, Thomas M et al. Radiother Oncol. 2021 Mar;156:102-112. doi: 10.1016/j.radonc.2020.11.032. 3, Hoffmann L et al. Radiother Oncol. 2022;172:32-41. doi: 10.1016/j.radonc.2022.04.029.4, Skinnerup Byskov C et al. Acta Oncol. 2025(13)64:406-414. doi: 10.2340/1651- 226X.2025.42774. Keywords: esophageal cancer, clinical trial, study framework from framework to plan: a barrier and facilitator analysis and implementation plan development for AI assistants in radiotherapy workflows Frederik Behets 1,2 , Rachelle Swart 3 , Martine Lipsch 4 , Rianne Fijten 1 , Maria Jacobs 5 , Andre Dekker 1 1 Clinical Data Science, Maastricht University, Maastricht, Netherlands. 2 Clinical Data Science, Maastro, Maastricht, Netherlands. 3 Faculty of Science and Engineering, Maastro, Maastricht, Netherlands. 4 Informatisering & Services, Maastro, Maastricht, Netherlands. 5 executive board, Maastro, Maastricht, Netherlands Purpose/Objective: AI assistants, such as Ambient and Generative AI, aim to reduce administrative workload in radiotherapy practice by converting clinician-patient conversations into structured medical summaries directly in the Electronic Health Record (EHR). Sustainable implementation depends on addressing barriers and facilitators across clinical, organisational, and individual levels. This study examined determinants, Digital Poster 4293
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