Clinical Trial Diversity Demands Looking at the Whole Patient

When discussing diversity in clinical trials, intersectionality means expanding criteria beyond age, ethnicity, sex, and race.

While clinical trial diversity may appear to be on the backburner due to the US administration’s downplaying of DEI, there still remains a global scientific mandate for it. In fact, the project READI —Research in Europe and Diversity Inclusion — a public-private partnership funded by the Horizon Europe Innovative Health Initiative (IHI) — launched early this year. Its main objective is to enhance the representativeness of underserved populations in clinical studies.

In an effort to continue the dialogue on diversity, Citeline participated in a panel discussion at ACRP 2025 titled “Clinical Trial Diversity & Intersectionality: Looking at the Whole Patient.” Citeline’s Fenwick Eckhardt, Senior Manager and Diversity Lead, was joined by Meghan McKenzie, Director of Health Equity and Clinical Research, Genentech's Chief Diversity Office; Sylvia Baedorf Kassis, Program Director, Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard; and Behtash Bahador, Director, Health Literacy, Center For Info & Study on Clinical Research Participation (CISCRP).

Acknowledging recent changes in US policy, Citeline’s Eckhardt said of the Federal Drug Administration (FDA) guidance — while currently not mandatory — requiring study sponsors to submit a Diversity Action Plan (DAP): “One big win for diversity and representation in clinical trials has been the publication of this draft guidance … which outlined the expectations or suggestions for what should be submitted in order to increase representation in clinical trials.” Beyond race and ethnicity, Eckhardt said there are “a multitude of considerations that feed into what actually makes a patient and how we should be framing these clinical trials to be representative of that.” Gender, age, and pregnancy status are just a few of those factors.

She detailed what should be included in a DAP:

• Rationale and goals: The sponsor’s rationale and goals for clinical study enrollment, separated by age, ethnicity, sex, and race
• Methods to meet goals: How the sponsor intends to meet those goals
• Consideration of diversity dimensions: Extending beyond age, ethnicity, sex, and race
• Waiver requests: Must follow the agency’s criteria and process

Eckhardt noted that many DAP goals are supported by epidemiology data. “So it really highlighted a need for incorporating quality data,” she said, “and ensuring that they were integrating data that was wholly representative of the patients that the intervention was intended for.”

She added that race is not consistently captured across the globe; “we need to be conscious of that when we're incorporating data. And we could have this conversation about all these additional aspects of the patient like sex, age groups, ethnicity. We need to be very conscious of how this data is being captured across the world and not based all of our perspectives based on what we see in the United States, especially for these more global trials.”

So many insights go into capturing the whole patient, Eckhardt said, and these “diverse insights really do require diverse datasets.” She added that Citeline, as a data and insights provider, is often tasked with what different datasets can be pulled to be truly representative of these patients. “We look at epidemiology data that's influencing those enrollment goals, real world data is always the first kind of dataset that we're talking about. … And then also looking at social determinants of health or SDOH data, clinical investigator and site patient access , census and survey data and so many more resources. These different datasets really can be pulled together in order to create that full picture of that patient. … At Citeline, Sitetrove’s Global Patient Insights pulls together US medical claims, electronic medical records, that epidemiology data.”

McKenzie, in the Inclusion and Belonging office at Genentech, spoke about the role of sexual orientation gender identity (SOGI) data in clinical research. She pointed out that sexual gender minority patients have high disparities with respiratory disease and certain types of cancer. “So when we don't collect sexual orientation and gender identity,” she said, “we don't understand if there's health outcome differences or disparities in this community. And we can't bid bridges to help people get into clinic much less clinical trial.”

“Othering” is a big barrier to treatment and trial participation. “If we don't create a safe space for patients, that it's safe for them to tell you who they are and what their social drivers of health are, then they may not get treated.” She told of a patient in Mississippi who was scared to come out to his doctor and ultimately died of AIDS. “So it's up to us to create the safe space.”

McKenzie said the National Institutes of Health (NIH) historically has recommended SOGI collection for the trials it funds. While today might be a different story, she said, the Academy of Sciences and American Medical Association (AMA) support collecting SOGI data to better understand healthcare disparities.

According to the Gallup organization, about 9% of the US population identifies as LGBTQ. Among Gen Z, the figure climbs to about 20%. “So we have a growing minority majority population,” McKenzie said, “we need to make sure we can build trusted relationships with.”

Her advice? “Don't disenfranchise the very community you're trying to serve.”

In her presentation, Kassis explained that MRCT is an applied policy center, focusing on the conduct oversight, ethics, and regulatory environment for clinical trials around the world. Its vision has always is to improve the integrity, safety, and rigor of clinical trials around the world. “And,” Kassis said, “the way that we do that … is engaging diverse stakeholders from across the ecosystem, including patients and patient advocates, IRBs, sponsors, investigators.”

Kassis said that “when we don't have representation in our trials, it limits our scientific knowledge of the safety and efficacy of medical products and interventions in certain populations. It also limits access to the latest scientific advances for these groups as clinical trials are increasingly part of clinical care.”

One of the MRCT Center’s initiatives is the convergence project, aimed at increasing access to clinical trials. The action plan, including the eight domains shown above, was developed with the MRCT Center, the Clinical Trials Transformation Initiative, (CTTI), Milken Institutes Faster Cures, and the National Academies of Science Engineering and Medicine.

Bahador of CISCRP rounded out the presentation by starting with the concept of intersectionality. He explained that CISCRP’s mission is to understand and improve the experiences that people have in clinical research and to empower and educate patients, the public, and clinical research professionals. Toward that end, he discussed several community outreach and education activities that CISCRP conducted, with a focus on accessibility.

One project, Journey to Better Health, is a mobile education unit on clinical research and awareness. An important facet of this work, Bahador said, is that “we partner with local individuals, people who are prominent in the community. Sometimes it's individuals involved in the faith community. Sometimes it's individuals involved in the community health and other times it's just volunteers that sort of have that energy and just are waiting to be activated, waiting to be doing something important for their community.”

Bahador said he tries to acknowledge some of the issues there have been with clinical research, particularly when it comes to mistreatment of communities who have been underrepresented in clinical research, but also to raise awareness about different ways to engage in clinical research. All the videos and brochures were in both English and Spanish.

Surveys of those who visited the mobile unit showed an improved understanding of clinical research, higher interest in learning more about research, and more willingness to participate in research. A follow-up survey about a month later revealed that visitors had talked to friends and family about clinical research.

In determining communities to survey online, Bahador said CISCRP aims for inclusiveness: ethnic diversity, racial diversity, along gender lines, and also socioeconomic diversity. “It helped us make sure that these materials were culturally relevant, that we're talking about the right things, that we're talking about it in the right way, the language we're using is correct. And even that the images in design for some communities in particular, like the brochure we made for Asian communities, the brochure that we made for native and indigenous communities, the colors really matter to them. And so something like that, you would hate to not be able to reach people because you didn't get the right colors.” CISCRP also has materials designed are for LGBTQ+ populations, for caregivers or parents of pediatric patients, and age-appropriate materials for children.

CISCRP also offers professional education and training, whether it’s cultural awareness or cultural competence knowledge in terms of communication and health literacy skills. “What we hear over and over again from clinical research professionals is that same stuff you're telling the patients and the public. I need my team to hear that, right? And I need them to have it in a way that's engaging for them.”

In terms of engaging content, Bahador referred to a health equity and music infographic CISCRP created that talked about the importance of just societal listening. He mentioned the rapper his name is Black Thought, who has a line in a song: “Criminal records like record sales. Makin' heads or tails, we like Henrietta Lacks up in the cells.” Bahador said the rapper is saying how his community can't seem to break out of this cycle of incarceration, similar to how Henrietta Lacks’ cells have been perpetually used and incarcerated without the consent of her or her family. “It’s just an absolutely genius way that he is connecting these different social determinants of health and showing how multilayered and multifaceted the issues that folks from multifaceted the issues that folks from these communities face.”

During the Q&A session that followed, McKenzie emphasized the ongoing importance of diversity in clinical trials: “Inclusive research is here to stay.”