Abstract
ABSTRACT
Background
Equitable participation in clinical trials is essential for ensuring that research evidence is scientifically robust, ethically just and representative of the populations it is intended to serve. In Australia, culturally and linguistically diverse (CALD) populations remain underrepresented in clinical trials despite increasing national policy attention to equity and inclusion. This review synthesized empirical evidence and Australian policy and practice documents to examine factors influencing CALD participation in clinical trials.
Objectives
To synthesize evidence on CALD attitudes, perceptions and factors influencing clinical trial participation in Australia; examine reported barriers and facilitators; describe how CALD populations have been conceptualized across the literature; and identify implications for research, practice and policy.
Methods
A scoping review was conducted in accordance with Joanna Briggs Institute guidance and reported using PRISMA‑ScR. Five electronic databases were searched for English‑language primary studies published between 2006 and June 2025. Eligible studies examined CALD adults' perceptions, experiences or participation in Australian clinical trials. A targeted synthesis of Australian grey literature was undertaken to contextualize empirical findings within the national policy and practice landscape. Data were charted and synthesized narratively.
Results
Eight empirical studies and seven Australian policy and practice documents were included. Five themes emerged from the empirical literature: (1) willingness to participate exists but opportunity is structurally constrained; (2) language and health literacy are pervasive barriers; (3) cultural values, family involvement and trust shape participation decision‐making; (4) system‐level practices limit equity monitoring and inclusion; and (5) inconsistent implementation of feasible facilitators. Policy documents increasingly recognized these same structural determinants and proposed system‐level strategies to improve equitable participation; however, nationally consistent implementation and accountability mechanisms remain limited.
Conclusion
Clinical trial participation among CALD populations should be understood as a dynamic, multi‐level decision‐making process rather than a single recruitment or informed consent event. Although Australia's policy landscape increasingly recognizes the structural determinants of equitable participation, implementation remains fragmented. Future efforts should prioritize culturally responsive, evidence‐informed and measurable approaches that support equitable participation throughout the clinical trial pathway.
Patient or Public Contribution
This scoping review synthesized published literature and did not involve the direct collection of data from patients or members of the public. The analysis, interpretation and framing of the findings were directly informed by patient and community perspectives reported in the included studies, many of which involved CALD consumers, carers and community members. The review was designed to amplify these perspectives and identify system‑level changes to improve equity in clinical trial participation.