Background Clinical trials are considered the gold-standard for the evaluation of interventions in healthcare (Thomas, Aitken, Antonelli et al. Postgrad Med J. 2020;96(1139):564–569; Sibbald, Roland. BMJ. 1998;316:201). However, there is a lack of literature on clinical trials within hospice environments, despite evidence that describes multiple benefits reported by trial participants with advanced disease (Middlemiss, Lloyd-Williams, Laird, et al. J Pain Symptom Manage. 2015; 50(5):642–649.e1). Here, we report our experience, including barriers and facilitators, of conducting a clinical trial in two hospices with different research infrastructures.
Aims To describe the setup and local implementation of a multi-centre phase III clinical trial within two Marie Curie hospices.
Methods Nov 2022 – Jan 2023: Detailed protocol review, including resource requirements and identifying key roles within the clinical and research teams. Central Marie Curie research governance approval and local approval at each site. Communication with key members of the clinical team to define roles and responsibilities. Jan 2023 – Present: Finalising site-specific trial documentation. Site Initiation Visits (SIVs) by the sponsor to meet local clinical and research staff. Preparation of education/training sessions for the local clinical teams. Recruitment of trial specific research staff to coordinate the trial, oversee recruitment and data management.
Results Preliminary data highlight barriers and facilitators in the following themes: 1) the safety of participants and staff; 2) staff training; 3) communication between research and clinical teams; 4) trial management and 5) solutions required to deal with differences in research resources, including staffing constraints, at both sites. Key timelines: March 2023 – First site opened to recruitment with three patients recruited in first month; June 2023 – Second site due to open.
Conclusion Here, using a coordinated team approach with careful and considered planning, it has been possible to conduct a clinical trial within two different hospices. Good communication from an early stage between research and clinical teams was essential to ensure that all staff were on board and committed to the successful launch of the trial.
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