An Equity-Embedded, Protocol-Agnostic Pre-Trial Navigation Model for Canadian Blood Cancer Trials: Findings from the...

Background: Inequitable access to clinical trials persists in blood cancers despite ongoing equity, diversity, and inclusion (EDI) efforts. Despite the critical role of clinical trials in improving survival and outcomes, recruitment remains suboptimal, limiting patient access to potentially life-saving therapies. Practical and scalable approaches are therefore needed to address the non-medical barriers that hinder patient readiness upstream of enrolment. Methods: Myeloma Canada led a national, multi-phase initiative using human-centred design (HCD) to operationalize EDI in clinical trials. Following an initial systems level workshop, the two-day Phase 0 workshop used a HCD approach that convened a purposively selected multidisciplinary group of stakeholders to co-design operational solutions for non-medical barriers affecting trial participation for patients. Given the use of purposive sampling, the results should be interpreted as reflecting a balanced range of diverse, informed perspectives across the Canadian clinical trial ecosystem. Results: Participants identified persistent cultural, logistical, financial, and linguistic barriers, along with fragmented awareness of available supports. Across diverse personas and care settings, all groups independently converged on a human-centred, equity-focused pre-trial navigation model supported by simple digital tools, including AI-enabled infrastructure drawing on curated resources from validated sources with appropriate governance, privacy, and oversight. Digital tools were proposed to support, rather than replace, human support and to align with existing health system realities. Conclusions: This hypothesis-generating work proposes a feasible, sustainable, and scalable equity-embedded, protocol-agnostic navigation framework. Its external hub-and-spoke structure can reduce non-medical barriers, strengthen trial access and accrual, and enhance representativeness. Pilot implementation that assesses feasibility, uptake, workflow impact, equity effects, and implementation burden is warranted.