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Background About one-third of Australians in rural, regional, and remote areas have limited access to clinical trials, leading to increased 2019 government funding to improve access. Objectives To review experiences of conducting clinical trials in these regions, describe efforts to develop activity, and identify gaps for future research. Eligibility criteria English-language peer-reviewed literature reporting on clinical trial activity, development, implementation, or lessons learned in rural, regional, and remote Australia. We excluded protocols, non-peer-reviewed literature, urban-focused studies, and outcome-focused clinical trial reports. Sources of evidence A systematic search of Scopus (MEDLINE), Informit Health Collection, and CINAHL electronic databases was conducted from inception to September 2024. Charting methods Data were extracted using a bespoke tool iteratively developed from previous literature and piloting. Results Of 466 records identified, 435 were screened, 84 underwent full-text review, and 24 were included. Eighteen were empirical with diverse research methodologies, and six were non-empirical. A third of publications ( n = 8) reported on trials conducted in Victoria, and over half ( n = 13) focused on oncology clinical trials. A hybrid deductive-inductive thematic analysis identified four key themes: 1) perceptions of clinical trials, 2) clinical trial activity and capability, 3) participant recruitment, and 4) clinical trials involving First Nations Australians. Clinicians and patients generally viewed clinical trials as important; however, limited clinical trial capability and maturity constrained local health services. Studies reporting economic analysis suggested that conducting clinical trials closer to participants could reduce costs for those who would otherwise need to travel to take part. Evidence indicates that First Nations Australians have been systematically excluded from clinical trials due to culturally inappropriate study designs. Conclusion While trials are viewed positively, more research is needed to explore capability-building approaches that strengthen recruitment, minimise research costs, and ensure culturally safe approaches that support meaningful participation by First Nations Australians.
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Graffini et al. (2026) studied this question.
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