Understanding FDA’s guidance on Diversity Action Plans (DAPs)
The FDA’s Diversity Action Plans for clinical trials aim to improve health equity, data quality, ethical standards, and create clear regulatory guidelines. Following the close of the comment period in September 2024, final guidance is expected by late 2025, with mandatory implementation shortly after. Now is the time to strategize and adapt your clinical operations to meet these new standards.
Adapting clinical operations for diversity compliance
DAPs will require clinical trial sponsors and sites to innovate across patient recruitment, data collection, and patient engagement. Sponsors need to innovate their operations to ensure inclusivity and reflect the diversity of real-world populations. This shift is essential to generalize study findings and improve patient care.
Steps to prepare for DAP compliance
1. Enhance Patient Recruitment for Diversity
To meet diversity goals, expand your recruitment network to reach underrepresented populations. Work with community partners who can broaden your reach into geographies and communities where diverse patients live. Patient engagement specialists can help you understand local needs and cultural nuances, while also educating diverse populations on the benefits of clinical trials as a healthcare option, research opportunity, or altruistic endeavor. Other considerations include logistics like reimbursing participants for travel, childcare, or lost work hours, and provide flexible site visit schedules to ensure inclusivity and avoid inadvertently excluding specific populations.
2. Invest in Site and Patient Education
Equip clinical trial site staff with cultural competence training and ensure educational materials are clear, culturally sensitive, and can effectively engage with diverse populations. Building trust with participants from diverse backgrounds is key to successful recruitment and retention and to ensure that potential participants understand the importance, benefits, and processes of participating in clinical research.
3. Meet New Regulatory Standards
Sponsors need to enhance data collection and reporting processes to accurately document the diversity of trial participants and their efforts to achieve it. Sites need to implement robust systems for collecting and monitoring demographic data to ensure compliance with diversity guidelines. Regular reporting on diversity efforts and participant demographics will be required, necessitating efficient data management and reporting systems. Clinical sites, particularly busy and resource-constrained ones, will need more support to minimize site burden and allow staff to focus on patient care.
How Clariness can support your DAP goals
Clariness’s network of 15 million+ patients include 47% people of color, giving us unmatched reach for diverse recruitment. Our patient specialists team, composed predominantly of people of color, is trained to build trust and guide participants through the trial process. With our feasibility and simulation tools, we predict recruitment success based on your DAP metrics, offering actionable insights to refine strategies.
Reducing site burden with Clariness
While the main goal of sites is to provide exceptional patient care, operational burden already poses challenges. Administrative workload, under-resourcing, protocol complexity, regulatory and compliance issues, technology management and support, data management, financial constraints, and sponsor site visits are already significant burdens. Having completed 2.5k studies across all therapeutic areas and enrolling millions of diverse patients, Clariness understands the protocols and patient engagement strategies that work in diverse communities for diverse patient recruitment. Our experts serve as an extension of your team and can take on responsibilities such as patient education and engagement, medical records retrieval, screening, and scheduling site visits—even updating the site portal. This partnership ensures that patient care remains your priority while leveraging our expertise in patient engagement and recruitment.
Commit to greater health equity in clinical trials
Preparing for Diversity Action Plans is an opportunity to advance health equity, enhance the quality of clinical research, and meet the evolving expectations of the FDA. By embracing these changes, sponsors and sites can build a stronger foundation of trust with diverse communities, improve the inclusivity of clinical trials, and ensure that research findings are more representative of real-world populations. Clariness is here to guide you through this transition with expertise in culturally competent patient engagement, efficient recruitment strategies, and comprehensive site support.