November 8th, 2024 How to Prepare for FDA-Mandated Clinical Diversity Action Plans (DAPs) This blog is authored by Suzanne Harris, SVP of Marketing at Subjectwell and upcoming speaker at the Fierce Diversity, Equity & Inclusion Forum 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 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 or Patient Companions 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. 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. 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 SubjectWell Can Support Your DAP Goals SubjectWell’s network of 13 million+ patients include 47% people of color, giving us unmatched reach for diverse recruitment. Our Patient Companions 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 SubjectWell 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 1,345 studies across all therapeutic areas and enrolling millions of diverse patients, SubjectWell understands the protocols and patient engagement strategies that work in diverse communities for diverse patient recruitment. SubjectWell offers full clinical site support to help minimize site burden. 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. SubjectWell is here to guide you through this transition with expertise in culturally competent patient engagement, efficient recruitment strategies, and comprehensive site support. Read more: Accommodations boost patient interest in clinical trial participation
This blog is authored by Suzanne Harris, SVP of Marketing at Subjectwell and upcoming speaker at the Fierce Diversity, Equity & Inclusion Forum 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 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 or Patient Companions 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. 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. 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 SubjectWell Can Support Your DAP Goals SubjectWell’s network of 13 million+ patients include 47% people of color, giving us unmatched reach for diverse recruitment. Our Patient Companions 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 SubjectWell 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 1,345 studies across all therapeutic areas and enrolling millions of diverse patients, SubjectWell understands the protocols and patient engagement strategies that work in diverse communities for diverse patient recruitment. SubjectWell offers full clinical site support to help minimize site burden. 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. SubjectWell is here to guide you through this transition with expertise in culturally competent patient engagement, efficient recruitment strategies, and comprehensive site support. Read more: Accommodations boost patient interest in clinical trial participation
