DIVERSITY, EQUITY & INCLUSION


Enhancing health literacy not only facilitates better-informed consent but also builds trust with research enterprises and site staff, who benefit from improved communication tools themselves


across different populations. However, significant gaps remain in applying DEI principles beyond racial and ethnic diversity in trial populations, especially with respect to considerations of equity and inclusion. There are many other populations who are diverse across a myriad of other personal and cultural dimensions – including and certainly not limited to age, gender, and disabilities. The intersectionality of equitable access with socioeconomic factors and practical realities contributes to ongoing disparities. A crucial lack of organisational health literacy and cultural competency in communications, alongside persistent implicit and explicit biases, further exacerbates these issues. True equity and inclusion require improved partnerships in the research process, not just in trial participation. Engaging individuals in shared learning about research and understanding how to meet their needs is essential. Awareness of these complex issues is growing, and ongoing efforts are paving the way for broader, long-overdue changes. Inclusive research practices are evolving, with many working hard to ensure meaningful DEI priorities in research programs.


Health literacy and improved transparency Health literacy plays a crucial role in empowering patients and communities to participate effectively in clinical research and is an inherent aspect of equity. Historically, research study listings, consent forms, and study materials have been complex and


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difficult to understand, creating barriers to participation and informed decision-making. Efforts to improve health literacy have led to the development of more accessible and comprehensible research materials. Plain language summaries, visual aids, and interactive tools now help explain research processes, risks, and benefits in an easily understandable way. Enhancing health literacy not only facilitates better-informed consent but also builds trust with research enterprises and site staff, who benefit from improved communication tools themselves. Transparency, often viewed strictly as a


matter of regulatory compliance, has seen significant strides towards patient centricity. Improved openness regarding study design, data, and results enhances trust among participants and the public. Open access publications, clinical trial registries, and data-sharing platforms address concerns about selective reporting and improve research credibility. It is equally important that aggregate and individual results are made publicly available, with clear communication of how participants’ data was used and what was learned from their contributions. Following good health literacy practices in disclosing this information is critical for maintaining trust, engagement, and supporting the altruistic benefits of participation.


A holistic patient-centric approach to clinical research Integrating these efforts—patient and community engagement, reduced participation burden, DCTs, health literacy, transparency, and DEI—represents a holistic approach to modern clinical research. Each area supports and reinforces the others, creating a more cohesive and patient-centered research ecosystem. By addressing the needs and perspectives of patients and communities through dedicated time and resources, researchers can generate more accurate and generalisable findings and conduct trials more effectively and efficiently. Achieving better health outcomes through a more collaborative and equitable approach benefits all stakeholders, including patient communities, participants, the broader public, and the research community.


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