How to bring more Black Americans into clinical research: Address the root causes of medical skepticism

The word “Tuskegee” has long embodied the painful symbol of medical racism, epitomizing how ethnically uninformed research practices have harmed Black Americans.

It is impossible to erase this painful history. But we — one of us working for Tuskegee University, the other for Southern Research — are working on an innovative project to create a future in which Black Americans participate more fully in clinical research and share in its benefits.

Beginning in 1932, the infamous U.S. Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male tracked the effects of untreated syphilis in Black men from Alabama. These men were misled into believing they were being treated for “bad blood” and were denied proper treatment even after penicillin became available in 1943.

This study, which lasted until 1972, was just one example of medical racism. Before it, enslaved Black people were subjected to non-consensual medical experimentation. J. Marion Sims, often called the “father of gynecology,” experimented on enslaved Black women without anesthesia, based on racist beliefs that Black people felt less pain than white people.

Even today, the legacy of these practices lingers. During the worst of the Covid pandemic, Alabama had more deaths than births for the first time in its known history, driven by a disproportionate death toll from Covid in Alabama’s Black community. That grim statistic repeated itself in both 2021 and 2022. The high Covid death toll in Black communities was not due to more infections but because they have been disadvantaged by medical racism for decades.

In fact, Black people in Alabama and nationwide continue to experience higher rates of chronic diseases, lower life expectancies, and reduced access to quality health care than white people. During the peak of the pandemic, the cumulative effects of systemic racism became even more pronounced. Black Americans were about 2.4 times more likely to die from Covid than white Americans, with even starker disparities in Alabama. As Covid vaccines became widely available, uptake among Black Americans was also slower than white Americans, notably in communities geographically near to the site of the original Tuskegee experiment.

Long-awaited guidelines issued by the Biden-Harris administration and the Food and Drug Administration aim to establish more concrete requirements and best practices for ensuring diverse representation in clinical trials. Diverse clinical trials are essential to understanding diseases that disproportionately affect Black Americans and the Deep South.

But diversity guidelines and funding commitments alone are not enough, as demonstrated by NIH’s unsuccessful attempt to pay for cancer patients from marginalized backgrounds to travel to clinical trial sites.

Unfortunately, historical trauma and mistrust remain significant barriers. Real progress requires meeting communities where they are — both physically and emotionally — and addressing the root causes of medical skepticism.

To improve participation in clinical trials, we must work through trusted primary care networks. A key part of successful community engagement is understanding that clinical trials cannot be successful if they are perceived as distant and disconnected from the lived experiences of participants. By focusing research efforts on primary care networks — where trust is already established — programs can promote participation in a way that is meaningful and relevant to patients.

Southern Research is partnering with Tuskegee University on Catalyst, a project that aims to increase clinical trial participation among rural and underserved Alabamians by leveraging existing networks of trust between patients and their health care providers. Building on lessons learned both from Tuskegee’s history and from partnerships like Tuskegee University’s involvement in the National Institutes of Health’s All of Us program — which seeks to create a database with genomic, health, lifestyle, and environmental information from 1 million or more participants — Catalyst aims to build a genomic biobank reflective of the Deep South population. We believe that bringing research to the local level, through trusted channels, can foster trust and encourage greater clinical trial participation.

Catalyst’s culturally appropriate, community-based approach offers free genomic sequencing to rural and underserved Alabama residents through their primary care providers. These providers, already trusted by their patients, will receive clinically actionable health reports, ensuring that patients benefit from their own data. To further build trust, the project includes advisory boards made up of primary care physicians, nurses, pharmacists, subspecialists, and other clinicians who develop best practices for patient engagement.

Genomics is rapidly advancing, and it is essential that rural and underserved populations are not left behind. Population health programs should be designed with three key components.

First, actionable information must reach the hands of professionals who guide patient care. Information is power, and having access to clinically actionable health information can be life-changing. Programs like Catalyst provide genetic counselors who can offer individualized education to patients and providers.

Second, patients must be treated as individuals, not data points. The Robert Wood Johnson Foundation estimates that as much as 80% of health outcomes are driven by social determinants of health, yet busy health care practices often lack the resources to screen for them.

Third, patients must feel empowered to make informed decisions in partnership with their health care providers. The BECOME (Black Experience of Clinical Trials and Opportunities for Meaningful Engagement) Research Project found that only 40% of Black respondents were offered a clinical trial, but more than 80% said they would consider participating if asked. Catalyst bridges this information gap by offering direct-to-patient clinical trial notifications, enabling patients to make informed decisions in partnership with their trusted providers.

In Alabama, there are several programs implementing versions of these strategies, including the Alabama Genomic Health Initiative and the eMERGE Network at UAB. Leaders from both programs are represented on Catalyst’s advisory boards to harmonize data and create collective impact for patients and communities. These efforts aim to inform future drug discovery and precision medicine targets, improving health outcomes for rural and Black Americans on the same soil where unethical medical experiments once took place.

By addressing the structural barriers to clinical trial diversity — providing participants with immediate, actionable health insights and prioritizing community engagement — we can shift the narrative from research subjects to research partners. Patients will directly benefit from their involvement in shaping the future of medicine.

The path to healing inequities is paved by building a health care research ecosystem that genuinely listens to and engages with the communities it aims to serve. The guidelines set by the FDA are an essential first step, but true progress will only come when genomic initiatives prioritize the science and the humanity of the populations that they aim to uplift. Personalized medicine offers transformative potential, but only if all communities have a stake in its benefits, starting with the patient.

Learning from the sins of the past and carrying their lessons into the future can yield a more prosperous future for Black Americans.

Khalilah Brown, M.D., is the vice president of medical affairs and patient advocacy at Southern Research and project lead for Catalyst. Stephen Sodeke, Ph.D., is the resident bioethicist and professor of bioethics at the Center for Biomedical Research at Tuskegee University.