January 15th, 2025 Bridging the Gap: Why Diversity Action Plans Are Critical in Clinical Trials This blog is authored by Shay Staples, VP of Customer Success and Operational Excellence at SubjectWell. As an African American woman, I’ve seen firsthand how disparities in healthcare can profoundly affect marginalized communities. These disparities are not only unjust but also preventable. With clinical trials, diversity isn’t just a matter of equity, but also one of efficacy and safety. With the implementation of the Diversity Action Plan (DAP) requirements in July 2025, the clinical trial industry is taking a monumental step toward addressing these inequities, but the journey still demands urgency, commitment, and understanding. The Current State of Diversity in Clinical Trials Clinical trials conducted in 2024 still reveal a glaring gap in the representation of diverse populations. According to recent studies, less than 5% of clinical trial participants are from Black or African American communities, even though we account for over 14% of the U.S. population. This underrepresentation not only skews the data used to develop treatments but also undermines trust in the healthcare system among minority groups. This disparity is even more pronounced when it comes to women’s health. Historically, clinical trials have often excluded women, leading to treatments and medications that do not account for biological differences. For example, heart disease, the leading cause of death for women, has been under-researched in female populations, resulting in diagnostic and treatment gaps that have cost countless lives. A Painful History: Tuskegee and Henrietta Lacks The mistrust of the healthcare system within Black communities is not unfounded. The Tuskegee Syphilis Study, which ran from 1932 to 1972, is a dark chapter in American medical history. In this study, hundreds of Black men were denied treatment for syphilis without their consent, even after penicillin became the standard of care. This blatant disregard for human dignity and life has left a lasting scar, fueling skepticism about participation in clinical research. Similarly, the story of Henrietta Lacks highlights the exploitation of Black bodies in medical research. In 1951, cells taken from Lacks without her knowledge or consent became one of the most important tools in medicine, leading to groundbreaking discoveries in cancer research, vaccines, and more. Yet, her family received no recognition or compensation for decades, underscoring the systemic inequities in how contributions from Black individuals are valued. My Personal Experience With A System in Need of Empathy As a Black woman, I’ve personally experienced the biases and lack of empathy that drive mistrust in the healthcare system. When I visit the doctor and complain of pain, I am often met with skepticism rather than care. It is frequently assumed that I might be seeking drugs or dismissed under the harmful stereotype of the “strong Black woman.” More often than not, there is no blood work or X-rays ordered, and no further diagnostic tests are conducted. I’m simply sent home. Later, after seeing several other physicians, I found something seriously wrong. This lack of empathy and thoroughness is not unique to me. Stories like mine are all too common within Black communities. Even Serena Williams, a world-renowned athlete, faced dismissive treatment during her postpartum complications, nearly losing her life due to medical neglect. These experiences highlight why diverse populations hesitate to engage with the healthcare system—a hesitation rooted in lived realities of bias and neglect. Why DAP Requirements Are a Game-Changer Starting this summer, the U.S. Food and Drug Administration (FDA) will require sponsors to submit Diversity Action Plans as part of their clinical trial protocols. This mandate is a response to decades of advocacy from stakeholders who understand that the inclusion of diverse populations is essential for many things, including: Efficacy Across Populations: Medications and treatments must be tested in populations reflective of those who will use them to ensure they are safe and effective for all. Building Trust: Engaging diverse communities fosters transparency and trust in the healthcare system. Reducing Healthcare Costs: Noncompliance with DAP can lead to trial delays, regulatory setbacks, and missed opportunities to bring life-saving treatments to market. The Cost of Noncompliance Failure to comply with DAP requirements will have significant financial and reputational consequences for sponsors and CROs. A delayed or rejected trial due to inadequate diversity planning can cost millions in lost revenue, not to mention the opportunity cost of treatments that could save lives. Moreover, as the healthcare industry becomes more patient-centric, sponsors who fail to prioritize diversity risk alienating a critical segment of their consumer base. Patients and advocates are increasingly vocal about the need for equitable practices, and organizations that fall short will face public scrutiny. Our Commitment to Diversity and Engagement To address these challenges, we are preparing to certify clinical trial sites on how to engage empathetically with diverse populations to increase participation and build trust. This certification focuses on fostering cultural competence and sensitivity, which are essential for establishing meaningful connections with underrepresented communities. Additionally, our teams are trained extensively in diversity and inclusion practices. We are proud to have an exclusive, diverse team of patient companions who provide personalized support throughout the trial process. This approach has solidified our position as the #1 leader in patient recruitment, with a 48% diverse patient database as of today. By sustaining and growing this database, we ensure that our efforts align with the evolving DAP requirements and continue to deliver impactful results for all stakeholders. Looking Ahead to 2025 and Beyond While the DAP mandate is a critical milestone, it’s only the beginning. To truly address health disparities, there are certain steps stakeholders must take, including: Leveraging Technology: Use diverse global databases and advanced recruitment technologies to effectively identify and engage underrepresented populations. Collaborating with Communities: Partner with community leaders, advocacy groups, and healthcare providers to build trust and encourage participation. Measuring Impact: Continuously monitor and report on diversity metrics to ensure accountability and transparency. A Call to Action As we prepare for the implementation of DAP requirements, I urge every stakeholder in the clinical trial ecosystem to reflect on the broader implications of diversity in healthcare. This isn’t just about regulatory compliance; it’s about creating a system that serves everyone equitably. The lessons of the Tuskegee experiment and Henrietta Lacks remind us that diversity in clinical trials is not just a scientific imperative but a moral one. Addressing the disparities in women’s health and minority representation can heal longstanding wounds and pave the way for a healthcare system that truly works for all. Together, we can transform the landscape of clinical trials, making them a beacon of inclusivity and innovation. The cost of inaction is too great—not just in dollars but in lives. Let’s rise to the challenge and ensure that no one is left behind in the pursuit of better health for all. Learn more about SubjectWell’s commitment to Diversity Action Plans
This blog is authored by Shay Staples, VP of Customer Success and Operational Excellence at SubjectWell. As an African American woman, I’ve seen firsthand how disparities in healthcare can profoundly affect marginalized communities. These disparities are not only unjust but also preventable. With clinical trials, diversity isn’t just a matter of equity, but also one of efficacy and safety. With the implementation of the Diversity Action Plan (DAP) requirements in July 2025, the clinical trial industry is taking a monumental step toward addressing these inequities, but the journey still demands urgency, commitment, and understanding. The Current State of Diversity in Clinical Trials Clinical trials conducted in 2024 still reveal a glaring gap in the representation of diverse populations. According to recent studies, less than 5% of clinical trial participants are from Black or African American communities, even though we account for over 14% of the U.S. population. This underrepresentation not only skews the data used to develop treatments but also undermines trust in the healthcare system among minority groups. This disparity is even more pronounced when it comes to women’s health. Historically, clinical trials have often excluded women, leading to treatments and medications that do not account for biological differences. For example, heart disease, the leading cause of death for women, has been under-researched in female populations, resulting in diagnostic and treatment gaps that have cost countless lives. A Painful History: Tuskegee and Henrietta Lacks The mistrust of the healthcare system within Black communities is not unfounded. The Tuskegee Syphilis Study, which ran from 1932 to 1972, is a dark chapter in American medical history. In this study, hundreds of Black men were denied treatment for syphilis without their consent, even after penicillin became the standard of care. This blatant disregard for human dignity and life has left a lasting scar, fueling skepticism about participation in clinical research. Similarly, the story of Henrietta Lacks highlights the exploitation of Black bodies in medical research. In 1951, cells taken from Lacks without her knowledge or consent became one of the most important tools in medicine, leading to groundbreaking discoveries in cancer research, vaccines, and more. Yet, her family received no recognition or compensation for decades, underscoring the systemic inequities in how contributions from Black individuals are valued. My Personal Experience With A System in Need of Empathy As a Black woman, I’ve personally experienced the biases and lack of empathy that drive mistrust in the healthcare system. When I visit the doctor and complain of pain, I am often met with skepticism rather than care. It is frequently assumed that I might be seeking drugs or dismissed under the harmful stereotype of the “strong Black woman.” More often than not, there is no blood work or X-rays ordered, and no further diagnostic tests are conducted. I’m simply sent home. Later, after seeing several other physicians, I found something seriously wrong. This lack of empathy and thoroughness is not unique to me. Stories like mine are all too common within Black communities. Even Serena Williams, a world-renowned athlete, faced dismissive treatment during her postpartum complications, nearly losing her life due to medical neglect. These experiences highlight why diverse populations hesitate to engage with the healthcare system—a hesitation rooted in lived realities of bias and neglect. Why DAP Requirements Are a Game-Changer Starting this summer, the U.S. Food and Drug Administration (FDA) will require sponsors to submit Diversity Action Plans as part of their clinical trial protocols. This mandate is a response to decades of advocacy from stakeholders who understand that the inclusion of diverse populations is essential for many things, including: Efficacy Across Populations: Medications and treatments must be tested in populations reflective of those who will use them to ensure they are safe and effective for all. Building Trust: Engaging diverse communities fosters transparency and trust in the healthcare system. Reducing Healthcare Costs: Noncompliance with DAP can lead to trial delays, regulatory setbacks, and missed opportunities to bring life-saving treatments to market. The Cost of Noncompliance Failure to comply with DAP requirements will have significant financial and reputational consequences for sponsors and CROs. A delayed or rejected trial due to inadequate diversity planning can cost millions in lost revenue, not to mention the opportunity cost of treatments that could save lives. Moreover, as the healthcare industry becomes more patient-centric, sponsors who fail to prioritize diversity risk alienating a critical segment of their consumer base. Patients and advocates are increasingly vocal about the need for equitable practices, and organizations that fall short will face public scrutiny. Our Commitment to Diversity and Engagement To address these challenges, we are preparing to certify clinical trial sites on how to engage empathetically with diverse populations to increase participation and build trust. This certification focuses on fostering cultural competence and sensitivity, which are essential for establishing meaningful connections with underrepresented communities. Additionally, our teams are trained extensively in diversity and inclusion practices. We are proud to have an exclusive, diverse team of patient companions who provide personalized support throughout the trial process. This approach has solidified our position as the #1 leader in patient recruitment, with a 48% diverse patient database as of today. By sustaining and growing this database, we ensure that our efforts align with the evolving DAP requirements and continue to deliver impactful results for all stakeholders. Looking Ahead to 2025 and Beyond While the DAP mandate is a critical milestone, it’s only the beginning. To truly address health disparities, there are certain steps stakeholders must take, including: Leveraging Technology: Use diverse global databases and advanced recruitment technologies to effectively identify and engage underrepresented populations. Collaborating with Communities: Partner with community leaders, advocacy groups, and healthcare providers to build trust and encourage participation. Measuring Impact: Continuously monitor and report on diversity metrics to ensure accountability and transparency. A Call to Action As we prepare for the implementation of DAP requirements, I urge every stakeholder in the clinical trial ecosystem to reflect on the broader implications of diversity in healthcare. This isn’t just about regulatory compliance; it’s about creating a system that serves everyone equitably. The lessons of the Tuskegee experiment and Henrietta Lacks remind us that diversity in clinical trials is not just a scientific imperative but a moral one. Addressing the disparities in women’s health and minority representation can heal longstanding wounds and pave the way for a healthcare system that truly works for all. Together, we can transform the landscape of clinical trials, making them a beacon of inclusivity and innovation. The cost of inaction is too great—not just in dollars but in lives. Let’s rise to the challenge and ensure that no one is left behind in the pursuit of better health for all. Learn more about SubjectWell’s commitment to Diversity Action Plans
