Action without strategy is aimless, strategy without action is powerless.
EDITOR’S NOTE: This piece originally appeared in Health Affairs on May 6, 2021. This article will form the basis of the Global Health Equity Symposium during the annual HIMSS conference, scheduled to begin on March 14, 2022. It is being reproduced here in recognition of Black History Month.
Systemic racism is the monster under our collective bed, built into our most fundamental social structures and institutions. For underserved community members and community members of color, it impacts where we live, the quality of our education, how likely we are to encounter unethical policing, our access to voting, and crucially, our ability to access quality healthcare.
Consequently, any authentic discussion on improving inclusive engagement in clinical trials, as we plan for 2030, must, at a minimum, acknowledge systemic racism in our healthcare system as a precursor. For instance, COVID-19 is negatively impacting all of us in obvious ways. However, as the pandemic shines a bright light onto systemic racism, it is disproportionately impacting many of us in ways that are not always easy to see, measure, understand, or even acknowledge.
Systemic racism is itself a root cause of health disparities, and therefore it is one of the social determinants of health (SDoH). SDoH are the conditions in the places where people are born, live, learn, work, pray, play, age, and die. These conditions explain, at least in part, why some community members are healthier than others, and why many underserved community members are disproportionately impacted by a wide variety of chronic illnesses. The morbidity and mortality rates of community members of color are exponentially higher across almost every chronic illness. These chronic illnesses, in turn, leave underserved community members more susceptible to infectious diseases. In fact, the Centers for Disease Control and Prevention (CDC) reports that community members of color have been and continue to contract and die from COVID-19 in disproportionate numbers. African Americans, Native Americans, and Hispanic Americans are hospitalized at rates approximately four times higher, and dying at rates almost three times higher, than white, non-Hispanic persons.
These disappointing and complicated cycles erode trust in our healthcare system generally, and further damage the already fragile trust paradigm between the clinical trials enterprise and underserved communities specifically. Well-intended actions that are taken toward improving inclusiveness in clinical trials, but are not led by culturally appropriate strategies that consider SDoH, will continue to be blind in their efforts. As we contemplate what a more positive and inclusive clinical trials enterprise in 2030 might look like, breaking these cycles while equitably addressing the SDoH could be our most important task.
I have had hundreds of conversations about addressing SDoH and eliminating health disparities with community leaders and community members in underserved communities across the country. I have worked extensively at the intersection of underserved community outreach and engagement, and have created mutually beneficial and equitable partnerships between underserved communities and public and private healthcare stakeholders. My organization worked in partnership with the AME Church to build the official health information dissemination and data collection platform for its 2,000 congregations and 2 million members worldwide (www.amechealth.org). This is a platform that combines a community-facing web portal for congregants and community members, with a private, password-protected, socially networked back-end to connect and support the work of the clergy and health ministry staff.
In my private conversations with the leadership of both secular and nonsecular community-based organizations, the discussions invariably turn to SDoH, and specifically, systemic racism and lack of trust.
We spend a lot of time talking through the tactics and strategies needed to improve the health and well-being of their communities, including how to best create equitable partnerships with public and private healthcare stakeholders. In our conversations, the healthcare system and the clinical trials enterprise are generally seen as inextricably connected; however, when discussing the clinical trials enterprise as a separate entity, the levels of distrust are even higher. The wounds and emotions associated with the history of inequitable, racist, and even cruel treatment of communities of color within the clinical trial enterprise are still raw.
And while some faith and community-based leaders readily acknowledge the importance of their community members participating in clinical trials, significant frustrations remain. Questions that come up during these conversations include: “Why should the onus be on us to just suddenly become more trusting? What has changed within the clinical trials enterprise to earn our trust? Show me the list of what precisely is different from before?” These frustrations do not seem completely intractable, but they are steeped in a well-earned and historic lack of trust, exacerbated by the inability of stakeholders throughout the clinical trials enterprise to consistently and clearly articulate why they should engender trust. And logically, a lack of trust by the leadership of influential faith and community-based organizations can easily translate to community members as well.
Based on my work, a more inclusive clinical trials enterprise in 2030 will largely be defined by the number of equitable partnerships created with underserved faith and community-based organizations. The path to those potential partnerships begins by building trusting relationships with the leaders of these organizations. Fortunately for the clinical trials enterprise, many of these leaders are recognized as valuable subject matter experts on community engagement, and they are generally known, liked, and trusted by their community members. Their organizations remain historically embedded in their communities, and have dedicated missions to improve the health and well-being of their own community members. They are experienced and effective at community outreach, engagement, education, and activation. Many of them would be qualified and ideal choices to direct, consult, and/or collaborate in the co-creation of powerfully effective, culturally appropriate community outreach and engagement strategies and campaigns.
By creating an equitable and ongoing connection, there would be significant opportunities for co-learning. The clinical trials enterprise would have opportunities to ease frustrations and consistently answer questions. There would be ample opportunities to show community leaders and their community members exactly what has changed about the clinical trial process. There would also be opportunities to create an active workforce pipeline to identify, recruit, educate, and encourage the growth and development of principal investigators of color.
Conversely, and not to be understated, there would be ongoing opportunities for community leaders to educate clinical trialists, researchers, trial sponsors, and other key stakeholders on the histories of marginalization and distrust felt by communities of color. They could lead transparent discussions about where the real and perceived power lies in their own communities. They could lead and deepen the understanding of key stakeholders throughout the clinical trials enterprise on how best to build on existing community strengths by respecting and leveraging local knowledge and resources. These community leaders are seeking genuine partnerships with healthcare organizations, including those within the clinical trials enterprise, that protect the well-being, interests, and rights of communities and community members of color in longer-term, measurable, and mutually beneficial ways.
However, today many community-based organizations find themselves inundated with opportunities for “sponsorship” from healthcare payor, provider, government, academic, and pharmaceutical stakeholders (and politicians, whenever they find themselves up for re-election). Yet, community-based organizations are generally only seen as commodities, not equitable partners, by the healthcare stakeholders seeking to engage them. As a result, they are leveraged for their market access, market intelligence, and ability to collect data, but receive little benefit in return. Many times, community-based organizations are not factored into the sponsor’s budget, and instead are asked to volunteer staff and personal time to distribute information. Moreover, they receive negligible usable data back about their very own communities. This hampers the ability of community-based organizations to seek local foundation funding to strengthen their own work and organizations. And once again, valuable community-based organizations find themselves underappreciated, underutilized, and underserved.
Now is the time to resolve to address this imbalance, and clearly recognize the attainable mutual benefit of working equitably on culturally appropriate strategies and actions that are both purposeful and powerful.
As we look towards 2030, I optimistically envision a much more inclusive and equitable healthcare and clinical trials enterprise, which supports the development of a robust, culturally and linguistically appropriate, web-based social network that has trusted faith and community-based organizations at its core. One that strengthens and empowers the messengers by connecting community-based organizations with each other, and to the vast numbers of underserved community members they serve. One that does not view underserved community-based organizations simply as sponsorable commodities, but as valuable partners with critical insights and qualified leadership. One that consistently acknowledges the history of race-based inequities, from slavery until today, and is committed to change. One that is committed to educating, training, and developing principal investigators of color. One that seeks equitable partnerships to drive culturally and linguistically appropriate campaigns that improve the health and well-being of underserved community members. One that unites the resolution to take action with strategies that are needed to drive towards a more inclusive clinical trials enterprise in ways that will always be easy to see, easy to measure, easy to understand, and even easy to acknowledge.
About the Author: Silas Buchanan is the principal at the Institute for eHealth Equity, and chief executive officer of OurHealthyCommunity, a social impact firm with the mission to improve the health, economic opportunity, education, and civic engagement of underserved communities through the innovative use of technology.
Acknowledgements: The author thanks the staff of the National Academies Forum on Drug Discovery, Development, and Translation, including C. Shore, A. Wagner Gee, and J. Liao for contributing to the development of this blog piece.
Well, this is the last RACmonitor news edition of the year, so it’s time for my annual Hirsch’s Heroes. As a reminder, last year my
The Centers for Medicare & Medicaid Services (CMS) has published several new proposed rules regarding Medicare payments for 2025. In addition to updating payment rates,
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