Background: Despite advances in psoriatic disease research, many people living with psoriatic disease remain underrepresented in clinical trials, limiting the relevance of clinical evidence for all communities and reinforcing inequities in care. Moreover, access to clinical trials varies widely across regions, with some areas having little to no representation in clinical studies. Structural, social, cultural, stigma and presence of comorbidities are some also contributing factors to this participation gap. IFPA’s Breaking Barriers project was established to understand these lived-experience obstacles and to co-develop patient-centered educational and empowerment resources to address them.

Objectives: This project aims to understand the global perspective on barriers to clinical trial participation and to develop actionable resources and tools that empower engagement with clinical research and support trial organisers in improving inclusion and equity.

Methods: We established a multidisciplinary working group with patient representatives and dermatologists from diverse geographic regions, the Breaking Barriers working group. This working group actively participated in 1) identifying the barriers to clinical research and clinical trial participation, 2) providing feedback on the type of resources and materials to be created, and 3) tailoring the content to reflect and represent the different realities of people living with psoriatic disease in different regions of the world. Patient representatives were selected for their lived-experience expertise and experience as patient organizations representatives and to ensure regional representation across different regions, namely Europe, Asia, and Africa. Healthcare professionals were selected for their extensive experience working with underserved and underrepresented communities, ensuring balanced and complementary perspectives within the working group.

Results: Insights from the working group representatives across multiple regions highlighted broad and intersecting barriers to clinical trial participation among people living with psoriatic disease. Key barriers included: 1) Limited awareness and understanding of clinical trials, their purpose, and how to participate. This barrier is often linked to unclear or un-tailored messaging to those the trials are aimed to serve, often only available in English, and suboptimal doctor-patient communication, frequently constrained by limited consultation time. 2) Low trust in clinical research, including concerns about study methodology and uncertainty regarding personal benefit or impact on disease or quality of life. 3) Patients often feel like research tools and less like research partners, with trials focusing on clinical skin outcomes and not integrating what truly matters in daily life. 4) Stigma and sociodemographic barriers, such as limited inclusion of people from culturally and ethnically diverse populations, restrictive inclusion and exclusion criteria for enrolment. 5) Lack of specialists in the country or area of residence. 6) The limitations shaped by national health system priorities and funding structures, amongst others. Many of these barriers were reported even in regions where clinical trials are most frequently conducted. In contrast, people living in regions such as Africa and large parts of Asia face an additional and fundamental barrier: the scarcity or near-complete absence of clinical trials in their regions. Based on insights from the Breaking Barriers working group, the project has developed a range of resources, including awareness-raising materials highlighting unmet needs in clinical research and trials tailored for the general public and policy-makers; patient-focused educational tools such as a glossary of common terms, guides and brochures to inform and empower individuals living with psoriatic disease to seek trial opportunities in their region, to be used by patient advocates and organizations; a checklist for clinical trial researchers and staff, trial sponsors and regulators, to support more inclusive study design and recruitment; and lived experience testimonials from individuals who both have and have not been able to access clinical trials.

Conclusions: A patient-centered understanding of barriers to clinical trial participation reveals multifaceted challenges that extend beyond eligibility criteria alone. Inclusive research practices must address communication, trust, logistical constraints, and cultural relevance to ensure equitable representation in psoriatic disease research. Implementing clear guidelines for clinical trial sites to follow, aimed at improving inclusion of underserved communities is essential to reducing existing access barriers. In parallel, the project’s resources were designed to equip patient organizations with evidence and tools to advocate for policymakers to prioritize the establishment of clinical trials in countries and regions where none currently exist. By centering patient voices, not merely as participants but as active partners, from study protocol development to relevant outcomes selection, clinical research can better reflect the diversity of people living with psoriatic disease and improve the relevance and impact of current and future innovations.

REFERENCES: NIL.

Acknowledgments: NIL.

Disclosure of interest: Raquel Vaz Paid speaker at events hosted by Boehringer Ingelheim and Takeda Pharmaceuticals, Paid consultant for Takeda Pharmaceuticals and Johnson and Johnson, Research grant from Takeda Pharmaceuticals.