Identifying the priority challenges of facilitating national proton beam therapy clinical trials

Abstract

Purpose or Objective Since the UK’s first NHS high-energy proton beam therapy (PBT) centre became operational in 2018, a significant proportion of patients referred for treatment have been enrolled in clinical trials. External patient referrals from healthcare organisations across the whole of the UK has highlighted a need for greater research governance and the streamlining of complex PBT data transfer procedures compared to existing local radiotherapy trial processes. This work reports on the process of identifying the priority challenges with a view to improving the proton trial pathway using an evaluative methodology, the nominal group technique (NGT). Materials and Methods To identify the key issues surrounding the practical implementation of PBT clinical trials, the facilitation of patient PBT trial pathways and transfer of radiotherapy trial data, a modified NGT approach was used. Briefly, the 6-step modified NGT includes the presentation of a question to a group followed by silent, round robin, discussion, scoring and data combining phases (Table 1). A panel was convened comprising five research radiographers with experience facilitating patient pathways and reporting radiotherapy data in adherence with PBT trials. Participants were presented with the question: “What are the major challenges when implementing PBT clinical trials and facilitating PBT trial-related activities?” The results of the NGT were used to make recommendations informing local operational policy processes, which may provide guidance for new PBT centre’s as they become clinically operational. Results A total of 59 challenges were identified after combining lists generated by each panel member. Responses were clarified, refined through discussion and duplications were eliminated, resulting in 14 challenges progressing to the scoring and ranking phase. Participants individually selected 5 of the 14 challenges that they deemed most pertinent and distributed a score (out of a possible 10 points) across their 5 chosen challenges. Individual points were combined when the group reconvened generating a ranked, weighted order of responses from the cohort to the initial question. Two priority challenges scored the highest, with every participant allocating points to these issues. These were: 1) a lack of initial understanding of responsibilities of teams and who the relevant stakeholders were, and 2) the nature of the national PBT service requiring the provision of shared care across numerous multi-disciplinary teams and multiple sites, with each organisation having their own working processes. Conclusion This work has identified the need to develop shared protocols identifying and clarifying responsibilities of multiple stakeholders to streamline PBT trial processes, promote understanding of the respective responsibilities, and improve communication between centres referring patients for PBT and PBT trials. The NGT is an effective tool for reaching consensus and identifying context-specific priority areas for quality improvement.