From Words to Action: Advancing Efforts to Reduce the Racial Gap in Clinical Research


Despite repeated calls from the FDA, patient advocates, and scholars for the need to address demographic disparities in clinical research, White participants still remain overrepresented while racial minority participants remain underrepresented in clinical trials.

Image credit: Prostock-studio | Doctor checking measuring pressure on patient's hand pulse

Image credit: Prostock-studio |

“Years ago, my aunt Sherri was diagnosed with breast cancer. Though she ultimately ended up beating it, the challenges she experienced during the process to seek and obtain the right treatment was something she could not have foreseen. For example, while taking post-chemotherapy medicines, she experienced the most extreme and rare side effects every time she took the drug, despite her doctors who assured her that the odds of experiencing these severe but rare side effects were extremely low. Unsurprisingly, my aunt began to lose trust in the doctors who were treating her.

What my aunt experienced as an African American woman was hardly surprising, given the lack of representation of Black patients in drug development. In fact, African American patients are significantly underrepresented in oncology clinical trials, which are predominantly non-Hispanic White.1 Thus, the standard of care for cancer treatments is primarily informed by studies conducted on White participants, raising questions about the efficacy and safety for communities of color.” - Dezbee McDaniel

Stories like this abound in underrepresented communities in the United States, particularly among communities of color. Though there has been a growing movement in the drug development industry to address racial disparities in clinical research heightened by the recent social justice movement, much of these efforts have remained aspirational.

Despite repeated calls from the FDA, patient advocates, and scholars for the need to address demographic disparities in clinical research,2–4 a significant amount of progress is needed to close the gap, as evidenced by recent reporting that shows White participants still remain overrepresented while racial minority participants remain underrepresented in clinical trials.5

Requiring racial diversity in trials has not been mandated and consequently, has not become an actionable priority for many organizations conducting clinical research.

To illustrate, industry sponsors—despite accounting for 46% of US-based clinical trials—were less likely to report race/ethnicity data compared to US government-funded trials.5 In fact, a recent study conducted among sponsor organizations revealed that many organizations do not track key performance indicators related to underrepresented minority patients in clinical studies, creating blind spots that may impede their attempts to bridge health disparities.6

Strategies for reaching underrepresented racial minority communities in clinical research studies

Despite these setbacks, it is clear that addressing these disparities should be a priority.7,8 The question is, how to move forward to create sustainable and lasting change that will move the dial on reducing the disparities for underrepresented minorities?

Below we share findings from the Tufts Center for the Study of Drug Development gathered while conducting research on ways to tackle representation disparities in clinical research. We share tangible and actionable steps that drug development stakeholders can incorporate into their business strategy.

Actively seek and partner with community-based sites and minority-owned, minority-centered solution providers that can help target the population you are trying to serve.

The vast majority of clinical trials in the United States are being conducted in large research centers and university medical hospitals, which tend to cluster in urban areas.9 Though these centers provide access to clinical studies for people living in large urban cities, they may not be accessible for people living in more rural or remote parts of the country.

We recommend looking for opportunities to broaden your network to include community-based research sites. For example, in our most recent study examining racial microaggressions experienced by patients in clinical research, Tufts Center for the Study of Drug Development partnered with several key organizations to ensure that we reached a racially diverse sample.

We reached out to Latinos in Clinical Research, a non-profit community of clinical research site owners and site representatives serving rural areas across the United States with the mission to increase Latino participation in clinical research.

Next, we reached out to University of California–San Francisco’s Collaborative Approach for Asian Americans, Native Hawaiians & Pacific Islanders Research and Education (CARE) to reach Asian American and Pacific Islander (AAPI) participants. Lastly, we collaborated with CliniSpan Health, whose mission is to connect underrepresented racial minority groups, including African Americans, with clinical research studies by building digital communities that target underserved populations using a Digital Health Influencer (DHI) model.

In fact, 53% of the study’s participants were recruited using CliniSpan’s DHI model, allowing us to achieve our target recruitment within the projected timeline.

Be okay with extending your project timeline

Creating a timeline and achieving project milestones in a timely manner are imperative for all businesses and this is certainly true in the drug development industry, where cycle times are viewed and treated as important performance metrics.10 Though extending timelines by budgeting additional time may seem counterintuitive, it is a necessary step.

Expanding one’s network by searching for and building new relationships with community-based sites and organizations will take time, potentially pushing out key milestones and extending project timelines. Establishing and building trust within these organizations and their patient population likewise will take time.

However, investing the time to build these connections and establish trust means improved recruitment times in the future, as was notably demonstrated by the Morehouse School of Medicine, where after laying the groundwork to reach out the patients and build trust, they were able to recruit 100 patients—85% of whom were African American—in the first three months.


Implement consistent ways to measure or benchmark your organization’s progress to achieve racial representation in your clinical trials.11 This can be done in different ways and should be tailored to fit the needs and goals of the functional area or organization.

For example, socio-demographic data can and should be used to create dashboards or scorecards that show whether studies are meeting enrollment targets. Sites could implement patient experience surveys to collect information on the patients’ experience interacting with the site staff—from check-in to check-out—highlighting areas that could be improved.

The key is to be consistent and persistent in measuring these metrics. Efforts to benchmark should be built into the business strategy so that it can help keep your organization accountable and on track.

Prepare a team that is culturally competent

Ideally, organizations will have a research staff that is racially and culturally representative of the patient population being served. Indeed, research has shown that the racial and ethnic diversity of the research site is predictive of the enrollment of diverse patients, such that sites whose staff are racially diverse are more likely to enroll racially diverse patients.9

Developing a team that demographically and/or culturally mirrors the patient population you are trying to serve, however, is easy to espouse, but hard to enact. Moreover, simply trying to recruit more racial minority patients without a having a holistic plan in place that factors in the diversity and cultural competence of the staff will most likely backfire.

Most research sites in the United States are not racially diverse.9 Though we highlight the importance of staffing research sites with racially diverse professionals, we acknowledge that this effort takes time.

In the interim, a short-term solution while sites try to diversify their research staff, can be to implement cultural competency training, such as racial microaggression and bias training, and partnering with minority-owned and minority-facing solution providers who can help bridge the racial gap.


We have highlighted different levers that organizations can use to reduce barriers and increase racial diversity in clinical trials. The steps we provided are not overnight solutions and will require constant vigilance and long-term commitment from key stakeholders to continually engage patients even after the study ends to foster and build trust.

However, with consistent efforts—such as, raising awareness using digital influencers that mirror the target population and creating long-term partnerships with communities—these steps can be achieved and can help move the dial to make clinical trials more inclusive so that stories such as the one shared above become a thing of the past.


1. Riner AN, Girma S, Vudatha V, et al. Eligibility Criteria Perpetuate Disparities in Enrollment and Participation of Black Patients in Pancreatic Cancer Clinical Trials. Journal of Clinical Oncology. 40(20).

2. Cheung CK, Tucker-Seeley R, Davies S, et al. A call to action: Antiracist patient engagement in adolescent and young adult oncology research and advocacy. Future Oncology. 2021;17(28):3743-3756. doi:10.2217/fon-2020-1213

3. Bierer BE, White SA, Meloney LG, Ahmed HR, Strauss DH, Clark LT. Achieving Diversity, Inclusion and Equity in Clinical Research. The MRCT Center of Brigham and Women’s Hospital and Harvard; 2021.

4. FDA Diversity and Inclusion Strategic Plan, 2018-2021. Food and Drug Administration; 2017.

5. Turner BE, Steinberg JR, Weeks BT, Rodriguez F, Cullen MR. Race/ethnicity reporting and representation in US clinical trials: A cohort study. The Lancet Regional Health - Americas. 2022;11:100252. doi:10.1016/j.lana.2022.100252

6. Kim JY, Maria Paula BA, Granville C, Getz KA. Benchmarking Organizational Patient Engagement Capabilities in Clinical Research. Therapeutic Innovation & Regulatory Science. Published online 2023. doi:

7. Diversity, equity and inclusion: we are in it for the long run. Nat Med. 2021;27(11):1851-1851. doi:10.1038/s41591-021-01582-5

8. Giusti K, Hamermesh RG. Reducing Racial Disparities in Cancer Outcomes. Harvard Business Review. Published 2022.

9. Getz K, Florez M, Botto E, et al. Global Investigative Site Personnel Diversity and Its Relationship with Study Participant Diversity. Therapeutic Innovation and Regulatory Science. 2022;56(5):777-784. doi:10.1007/s43441-022-00418-9

10. Fantana AL, Cella GM, Benson CT, Kvedar JC. The Future of Drug Trials Is Better Data and Continuous Monitoring. Harvard Business Review. Published online May 2, 2019. Accessed September 29, 2023.

11. Kim JY, Botto E. What is hindering the drug development industry from achieving diversity, equity and inclusion in its workforce? Nat Biotechnol. 2023;41(6):878-879. doi:10.1038/s41587-023-01817-5

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