The lack of diversity in clinical trials is one of the most pressing concerns confronting the clinical research industry. The recent FDA guidance for diversity in clinical trials calls on all clinical research sponsors and investigators to increase the racial and ethnic diversity of their trials, and many trials are also struggling to include enough patients who are older or disabled.
At the same time, the concept of frontier or community research sites is trending in the U.S., with organizations like CVS and Walgreens implementing clinical trials at their pharmacies. The question then becomes: will frontier sites improve the lack of diversity in clinical research or make it worse?
Frontier sites, like pharmacies, labs, and community clinics, can bring trials closer to where patients live. But this will only increase diversity if sponsors and investigators set up trials in medically underserved neighborhoods and build relationships with communities before trials begin. Keep reading to learn how to make this possible.
How diverse are clinical trials?
The demographics of U.S. clinical trials don’t accurately reflect the American population when it comes to race, age, or disability status.
A study found that the patients in vaccine clinical trials were:
- 11.6% Hispanic/Latinx
- 10.6% Black/African American
- 5.7% Asian
- 0.4% American Indian/Native American/Indigenous
By contrast, the actual U.S. population is:
- 18.9% Hispanic/Latinx
- 13.6% Black/African American
- 6.1% Asian
- 1.3% American Indian/Native American/Indigenous
Black, Latinx, Asian, and Indigenous patients are all underrepresented in trials, with only white patients being overrepresented. This lack of racial diversity leads to less scientifically accurate trials. 19% of all new treatments approved by the FDA have different effects depending on a person’s race or ethnicity, making diversity a scientific as well as moral imperative.
Older patients are also often underrepresented in trials. Although 16% of the U.S. population is over the age of 65, only 12.1% of participants in vaccine clinical trials were 65+. When COVID-19 vaccine and treatment trials first started, 61% excluded adults over 65, though this problem was later partially corrected.
Older adults are also underrepresented in oncology clinical trials, even though the risk of a cancer diagnosis rises as people get older.
Including older adults in clinical research, where feasible, will help investigators see how medications impact the people who are most likely to need them. Older patients also have a higher chance of being on multiple medications, which can provide valuable information about medication interactions.
Patients with Disabilities
People with disabilities suffer some of the highest rates of exclusion from clinical research. One study found that children with disabilities were excluded from 90% of developmental studies. 74% of those studies did not explain why the children were excluded, making it impossible to tell if there was a medical reason behind it.
In another review, 84.1% of studies failed to justify or poorly justified why they excluded people with disabilities. This means patients could be excluded from trials they may be eligible for and eager to participate in, and investigators may have inadequate information on how medications impact patients with multiple illnesses or disabilities.
To learn more about the diversity problem in clinical trials, check out the following resources:
Why is there a lack of diversity in clinical trials?
Clinical trials don’t enroll enough patients over 65, patients with disabilities, and patients of color for a variety of reasons:
- Clinical trials aren’t easily accessible to many patients
- Some patients don’t trust that trials serve their best interests
- Patients may not know that trials are available
Each of these problems has multiple causes and will require multiple solutions.
Trials Aren’t Accessible
Historically, clinical research has been concentrated at academic medical centers (AMCs) in major cities. That means trials are only available to patients who live nearby or can afford to travel. But 70% of the U.S. population lives more than 2 hours away from the closest AMC.
The need for travel prevents many patients from joining clinical trials. In a study of patients living with chronic illnesses, 42% of the respondents said they didn’t join trials because of the inconvenience of travel. This was the most common reason patients gave for avoiding trials, even above concerns about side effects (30%) and the chance of getting a placebo (23%).
Traditional, site-based clinical trials are especially inaccessible for:
- People who work hourly jobs
- People who rely on public transportation
- People who are caregivers
- People who live with disabilities or chronic illnesses
Patients with learning disabilities or neurodiverse patients may find traditional research sites especially difficult to navigate. Having to travel to the site, constantly interact with people, quickly read consent forms, and make on-the-spot decisions can push patients away from trials.
If we want to increase the diversity of our clinical research, we need to move trials to sites closer to patients, like local doctors’ offices and pharmacies.
We should also give patients the opportunity to submit data from home–while remembering that not all patients have equal access to technology. In the Research Revolution session, “Designing More Diverse and Inclusive Trials,” Carlos Orantes, Tiffany Whitlow, and Danielle Mitchell emphasized that technology is only helpful if it’s easy-to-use and if patients have WiFi and devices.
But lack of access to sites or technology isn’t the only challenge that keeps patients from joining trials.
Some Patients Distrust Trials
In one survey, 50% of Black respondents and 42% of Latinx respondents said people chose not to participate in clinical research because of a lack of trust.
Another study found that 61.8% of patients believe doctors withhold information during clinical trials, and 53.1% believe doctors will discriminate against them because of their race or ethnicity.
Much of this distrust comes from past unethical trials, like the Tuskeegee syphilis study. The Black men involved in the study were not told what they were being treated for, and the doctors withheld effective treatments for syphilis when they became available.
Distrust can also stem from a lack of diversity among investigators. In the U.S., only 5.8% of physicians identify as Latinx and only 5.0% as Black or African American. 40% of participants would be more likely to join a trial if they could speak to an investigator who shares their background, but this often isn’t possible.
Patients Don’t Know Trials Are Available
51% of Latinx patients and 48% of Black patients believe people don’t enroll in clinical trials because of a lack of information. 68% of African American respondents and 67% of Hispanic respondents also said their doctors had never mentioned medical research to them.
These numbers align with a study from patient advocate Stephanie Walker, which found that only 40% of Black women with metastatic breast cancer were told about clinical trials, though 80% would have joined a trial if given the option.
Walker speculates that unconscious bias may be at work, with physicians jumping to the conclusion that underrepresented patients aren’t interested in trials. It’s also possible that the physicians aren’t aware of which trials are available and don’t have time to do the additional research to find out.
How Can Diversity Be Increased in Clinical Trials?
Clinical research sponsors and investigators can try a few strategies to address the issues of accessibility, trust, and knowledge listed above.
Potential strategies include:
- Employing frontier sites to make trials more accessible
- Engaging with communities to build trust in and awareness of trials
These strategies also align well with the FDA’s 2022 guidance, which is an important benefit for sponsors or investigators who want their treatments approved in the U.S.
Here’s how these strategies work and why they’re able to increase representation.
Employing Frontier Sites to Make Trials More Accessible
Frontier sites are organizations that already provide care to patients but are new to clinical research.
- Community health clinics
- Local doctors’ offices
Although 2 in 3 patients live hours from the closest AMC, almost every patient lives near a doctor’s office or pharmacy. Participants can visit these frontier sites to have their blood drawn, get their blood pressure checked, and pick up medication without needing to take off work or travel long distances.
Patients might still have to visit an AMC for advanced procedures or scans, especially during high-complexity trials (like oncology trials). But they won’t have to spend hours in a car or on a bus for a simple check-in.
Past Successes with Community Sites
Involving frontier or community sites has also led to more diversity in past trials, like the SPRINT blood pressure trial. The SPRINT trial engaged 19 coordinating centers and 102 community sites. This allowed them to recruit 15,000 participants, more than their 9,000-participant goal, and 50% of those patients were people of color.
If coordinating centers and sponsors want to emulate the success of the SPRINT trial, they’ll need to work with frontier sites and use tech to bring trials to where patients are.
Learn more about frontier or community sites by exploring the following resources:
Engaging with Communities to Build Trust in and Awareness of Trials
81% of Latinx and 74% of African American patients said they would participate in a clinical trial if their doctor recommended one. This backs up the assertion by Andrea Bastek, Florence’s VP of Innovation, that many patients “look to leaders in their community or their long-time local physicians for advice about illness, therapy options, and clinical trials.”
But clinical research teams can’t wait until after a trial begins to build trust with patients and physicians. Sponsors and coordinating centers need to form long-term, working relationships with frontier sites that serve underrepresented patients. That way, patients can hear about trials from pharmacists and physicians they already trust.
“Being culturally aware is very important,” Carlos Orantes emphasized at Research Revolution. “You have to understand your surrounding community, not just your patient data.”
Cultural understanding could mean:
- Providing community workshops and discussions about clinical trials
- Offering physicians and pharmacists free clinical research training
- Asking members of the community how they like to receive information and what languages information should be distributed
This could mean providing community workshops and discussions about clinical trials. It could also mean offering physicians and pharmacists free clinical research training.
Clinical research sites and sponsors can also introduce physicians and patients to online clinical trial databases. However, it’s important to realize that many underserved patients don’t have access to reliable WiFi or a computer. That’s why it’s vital to give patients devices and WiFi access or offer in-person events as an alternative.
In-person events about trials could be held at community centers, libraries, and religious organizations. As Catherine Gregor, Florence’s Chief Clinical Trials Officer said in a diversity-focused webinar, “Patients shouldn’t hear of trials for the first time when they’re sick.”
Working with Frontier Sites to Increase Diversity in Clinical Trials
Bringing frontier sites like pharmacies, labs, and community clinics into clinical research can make a tremendous difference in patient diversity. When patients can visit community sites instead of traveling to an academic medical center for every visit, they can participate in trials without taking days off work or driving long distances.
But clinical research sponsors and coordinating centers can’t just open frontier sites. They also need to ensure those sites are located in medically underserved communities, and they need to reach out to those communities to build trust through workshops, discussions, and training for physicians.
To learn more about clinical trial equity and inclusion, check out our breakdown of the FDA’s most recent diversity guidance, which includes concrete strategies for reaching underserved patients.