AIMS: In oncology research, patient priorities (equitable access, reduced burden) and operational objectives (rapid recruitment, operational efficiency) are historically viewed as competing interests. This perceived disconnect creates barriers to clinical trial innovation, disproportionately impacting rare cancer and geographically underrepresented populations facing profound logistical hurdles. By collaborating on new operational models that align patient, clinical, and commercial goals, trials can generate endpoints that matter to every stakeholder simultaneously.
METHODS: To prospectively test this alignment, a co-designed Rapid Activation Decentralised Trial Model (RAD-TM) was implemented within a Phase I first-in-human oncology study (ClinicalTrials.gov: NCT06188702). This approach utilised national molecular screening to rapidly identify genomic subsets, alongside decentralised care pathways and targeted satellite site activation. The framework seamlessly aligned patient-centred and operational priorities around four core pillars: health equity, disease knowledge, return to trusted local care, and robust study performance.
RESULTS: Treating patient and operational priorities as shared outcomes yielded highly synergistic results. The co-designed model directly led to Australian sites contributing the highest global study recruitment. Crucially, the decentralised approach successfully dismantled traditional geographical barriers that typically exclude underrepresented communities. This transformed the early-phase study into a genuine treatment opportunity for rare cancer patients, with regional and rural individuals representing over a third of all study referrals. Furthermore, the program enabled the first Phase I participant to return to their local hospital for ongoing treatment.
CONCLUSIONS: The assumption that patient centricity and operational efficiency are inherently competing forces is fundamentally flawed. When co-designed around a shared purpose, these priorities become profoundly symbiotic, directly benefiting rare cancer populations. Our findings support a broader shift in trial design towards frameworks where patient-centered value and operational performance are treated as co-dependent, rather than competing, measures of success. Such a shift would drive research that is both more innovative and more inclusive of underserved cancer populations.