Barriers and Strategies for Inclusive Clinical Trials: Focus Group Insights on Inclusivity, Diversity, Equity, and Accessibility.

Abstract

Background: Clinical trials are essential for advancing healthcare, yet they often underrepresent key populations, which can limit the applicability of findings to populations for whom interventions are intended and perpetuate inequities in the evidence base. In Canada, practical, context-specific resources to support inclusive trial design and conduct remain limited.

Objective: To explore barriers, facilitators, and strategies related to equitable participation in Canadian clinical trials and to gather stakeholder input to inform development of an Inclusion, Diversity, Equity, and Accessibility (IDEA) toolkit for researchers.

Methods: We conducted two in-person qualitative focus groups with 20 stakeholders, including researchers, healthcare providers, patient partners, Indigenous representatives, and other participants with lived or professional experience relevant to clinical-trial participation. Audio recordings were transcribed and analyzed in NVivo 15 using an inductive thematic-analysis approach.

Results: Participants identified five barriers to inclusive participation: lack of trust; limited clinical-trial knowledge and health research literacy; language and communication challenges; logistical and regulatory challenges; and study burden and gatekeeping. Facilitators included community engagement, culturally relevant representation and outreach, multilingual and accessible materials, flexible and accessible trial delivery, and recruitment and retention supports. Stakeholders also identified priorities for a practical, modular Canadian IDEA toolkit.

Conclusion: This exploratory study identifies structural, relational, and operational factors that shape inclusive trial participation and provides context-informed priorities for an IDEA toolkit. The findings are not intended to represent all underserved communities, but they offer practical lessons that can be adapted across trial settings.