Palliative Care Clinical Trials: Building Capability and Capacity.

Abstract

Clinical trials are a key component of expanding the evidence base in palliative care. A key strategic objective of the Victorian Comprehensive Cancer Centre (VCCC), a multisite cancer center alliance, was to increase palliative care clinical trial expertise. The palliative care services within the VCCC alliance presented substantial trial development opportunities with large number of patients and established relationships, but few trial-active centers. Objectives: To establish a multi-site "Building Capability in Palliative Care Clinical Trials" program as a service development, and to assess the strategies, activities, and the outcomes resulting from this program. Methods: A series of strategies and activities were developed linked to the key program objectives of increasing the number of clinical sites and skilled clinicians conducting clinical trials, increasing the number of trials available and patients participating, broadening research opportunities in palliative care, and establishing the program sustainability. Results: In the two years of implementation, the program resulted in the establishment and conduct of several Phase 4 postmarketing pharmacovigilance studies, nine Phase 2 and 3 trials across five palliative care services, and a Phase 1 clinical trial. During the program, 150 patients were recruited to clinical trials, and 258 prospective pharmacovigilance monitoring cases were recorded. Five investigator-initiated trials were developed by clinical trial fellows and achieved competitive (n = 3) or commercial (n = 2) funding. Clinicians reported that undertaking clinical trials had increased attention to the evidence base of care provision, and increased service research activity more broadly. Long-term sustainability remains a challenge, particularly in the context of the COVID-19 pandemic. Conclusions: Clinical trials in palliative care services are feasible, acceptable, and result in increased attention to the evidence base of care. The strategies detailing the framework, activities, and outcomes have been collated to facilitate implementation of clinical trials in other sites and with other trial-naive disciplinary groups.