What’s Standing in the Way of More Diverse Clinical Trials? 

Clinical trials let researchers test new drugs, medical devices, and interventions to improve outcomes across many diseases. But in order for these studies to deliver the most impactful results, they need to include participants from different racial and ethnic backgrounds.

Historically, research participants have not reflected the diversity of the U.S. population. According to the National Cancer Institute (NCI), Black people make up about 5-7 percent of clinical trial participants in the U.S., despite accounting for roughly 13 percent of the total U.S. population. Additionally, data from the U.S. Food and Drug Administration (FDA) show that 76 percent of drug-trial participants were non-Hispanic white, compared with 58 percent of the U.S. population. 

Treatments and medical approaches need to be studied in populations that reflect the people who may ultimately use them. This is especially important for Black Americans, who experience disproportionate burdens of many chronic diseases and health conditions.

Several known barriers explain why clinical trials remain less diverse: lack of awareness, mistrust of the healthcare system, financial constraints, transportation challenges, and fear.

A recent study published in the Journal of Racial and Ethnic Health Disparities poses another challenge to greater representation in medical research: What if some barriers to diverse research participation come from the research team themselves?

What Did the Researchers Study?

The researchers interviewed 33 investigators and research team members who had participated in a workshop focused on inclusive research recruitment. The interviews took place about three months after the workshop and explored whether participants had been able to put inclusive recruitment strategies into practice. 

This study was qualitative, meaning that the researchers identified specific themes and experiences rather than testing a treatment or measuring clinical outcomes.

These themes included:

• Resources
• Socio-cultural context
• Hierarchy and decision-making

The participants largely came from health-science settings, and the sample was predominantly white women.

RELATED: Improving Diversity in Clinical Trials: A Personal Perspective

What Makes Diverse Recruitment Difficult?

According to the study’s findings, research teams can face several challenges when trying to make recruitment more inclusive, including:

• Time and money: Research teams may want to expand recruitment, but lack the resources needed to build community relationships, provide transportation, hire outreach staff, or change established procedures.
• Established research practices: Teams may rely on familiar recruitment practices even when those approaches don’t reach diverse communities.
• Team culture: Some researchers may be more open to inclusive recruitment than others, making it difficult to introduce new practices.
• Leadership support: Research staff may have ideas for improving recruitment but lack the authority to change study procedures without support from investigators or other leaders.
• Community relationships: Researchers may worry about approaching communities in unfamiliar ways or not having all the answers.

Some Research Teams Were Able to Start Making Changes

Despite these barriers, 29 of the 33 interview participants (88 percent) described implementing some type of inclusive recruitment strategy within the three months after the workshop.

Some examples included:

• Creating new recruitment guidelines or protocols
• Developing relationships with community partners
• Considering new team roles, such as interpreters or outreach specialists
• Exploring ways to increase the diversity of research teams

The researchers noted that many of these changes were relatively modest or still within the early planning stages.

What This Could Mean for Black Patients

When Black communities are underrepresented in medical research, conversations about clinical trial participation can easily focus on whether patients trust researchers or are willing to participate.

But the latest study adds another piece to the conversation: research teams and institutions also have a responsibility to create meaningful opportunities to participate. 

The onus should not be on Black communities to improve representation in clinical trials. Research teams also need to examine how their own recruitment practices may create barriers and take steps to make research more accessible to people from historically underrepresented communities.

What Can Researchers Do Differently?

Researchers can encourage more diverse clinical trials by:

• Recruiting beyond traditional academic medical centers
• Partnering with trusted community leaders
• Considering transportation or other logistical barriers to participation
• Using interpreters or other support when appropriate
• Giving community members a meaningful voice in research design and recruitment

Change won’t happen overnight, but small, yet meaningful steps can lead to better representation in clinical trials.

What Are the Study’s Limitations?

While the study’s findings show promise for more diversity in clinical trials in the future, a few limitations exist:

• The sample was small, with 33 participants.
• Participants were drawn from people who had already chosen to participate in an inclusive-recruitment workshop.
• The study was conducted within a predominantly white institution in a majority-white state, and 88 percent of the participants identified as white.
• The study’s authors caution that experiences could be different for Black, Asian, Native American, and other researchers and research staff

This study is only one piece of the puzzle. Future research will need to examine larger populations of clinical researchers to truly understand what needs to be done to diversify medical research.

What Does This Mean for Someone Considering a Clinical Trial?

If you’re thinking about participating in a clinical trial, here’s what you should know:

• You don’t have to decide to join a study simply because researchers are trying to improve diversity.
• Ask what the study involves, why you’re eligible, what your responsibilities would be, and what risks or costs are involved.
• Ask whether transportation, parking, childcare, or other participation costs are covered.
• Ask who you can contact with questions during the study.
• Remember that joining a clinical trial is always your choice.

RELATED: 15 Questions to Ask About Clinical Trials

Diversity Starts Before a Patient Is Asked to Join a Clinical Trial

Improving diversity in clinical research requires changes within research teams and institutions, not simply outreach to patients. For Black patients, that means creating research opportunities that are accessible, respectful, community-centered, and designed with diverse participants in mind.

The takeaway? Patients can ask questions about a clinical trial, but researchers and study sponsors also have a responsibility to make participation possible and meaningful.