Expanding Racial and Ethnic Participation in Clinical Trials Key to Health Equity

Successful development of any new medicine, treatment or therapy is reliant on its ability to meet the needs of patient populations in demand of those treatments. Clinical trials is where the rubber meets the road so to speak, but has long been an area of scientific research void of representational racial and ethnic participation.

According to a study from Syneos Health titled “How to Boost Racial Ethnic and Gender Diversity in Clinical Research,” 83% of clinical trial participants were white in 2018. While Black and Hispanic people make up nearly 40% of the population, they represented just 2% and 1% of clinical trial participants, respectively.

Participation and access has historically been low for a variety factors, but it typically comes back to three key issues, according to an analysis from the National Center for Biotechnology Information:

  • Issues of trust for communities that have historically been underserved, deceived or exploited by the scientific and medical communities
  • Physician or researcher bias
  • Structural hurdles such as access to care or health education

Changing Criteria

When examining the criteria that is used to determine who is eligible for a clinical trial, researchers suggest that in some cases, the criteria unnecessarily excludes certain target patient populations. According to Food and Drug Administration guidelines, this can lead to a failure to discover vital safety information about the drug under investigation. Target populations might be unintentionally excluded when certain comorbidities are excluded or included in a trial.

“For instance, in diabetes trials in many instances, the eligibility criteria excludes people with hypertension,” Sasha Tyndale, Director of Patient Engagement and Inclusion Solutions at AbbVie (No. 23 on the 2022 Fair360, formerly DiversityInc Top 50 Companies for Diversity list) said. “But hypertension is very common within the Black community and they’re also at a higher risk of having type two diabetes, so we need to think about how to balance those as we work to increase representation within our clinical trials.”

In addition to the eligibility barriers some communities face in gaining access to these trials, there’s also the barriers many face in terms of what it takes to participate. Clinical trials can be time consuming or may require regular visits to a study site. That isn’t always realistic for communities that are disproportionately represented in jobs that require them to be in a physical location or work long hours.

“We have to be able to balance maintaining the integrity of our protocols with our understanding of people’s lifestyles and the challenges they face,” Kim Ribeiro, Head of Diversity and Patient Inclusion at AbbVie, said. “While everything else in society is pretty much on-demand, clinical trials are one of the few areas where we’re often asking the patient to come to us. For participants, this may involve taking time off work, traveling and spending long hours at the study site. That’s a hard sell for anyone, especially those who don’t have the luxury of working remotely.”

Actions to Expand Racial and Ethnic Participation

This issue is tied to health equity at the root level and health equity is something that businesses are beginning to pay closer attention to. So, what can companies do about this issue? All companies can drive health equity through education, and many are moving the needle on broader issues in health equity through a variety of community partnerships.

For those with a vested interest in clinical trials, namely pharma companies, finding ways to increase access and participation must be more than just lip service. It’s a business imperative.

At Eli Lilly and Co. (No. 5 on the 2022 Fair360, formerly DiversityInc Top 50 list), the push to address the issue of representation within clinical trials is part of the company’s broader Racial Justice Initiative and is outlined in its Racial Justice Progress Report. One key action was changing where the trials take place.

In 2021, Lilly accelerated its efforts to improve diversity in its clinical trials, including its oncology and Alzheimer’s studies using a decentralized clinical trial approach. The company also established a partnership with the Network for Excellence in Healthcare Innovation (NEHI) to form a Community Focused Research Organization (CFRO) focused solely on driving diversity in clinical trial participation.

Lilly stood the effort up with an initial $500,000 in seed funding.

“Our clinical trial population must reflect the patient population the trial medicine may treat,” Kelly Copes Anderson, Global Head of DEI at Eli Lilly and Co., said. “We are constantly evolving our strategies to enhance diverse representation in our trials by establishing novel partnerships, identifying a diverse range of trial sites and investigators, expanding accessibility and convenience and raising awareness via digital outreach campaigns.”

At Abbott (No. 3 on the 2022 Fair360, formerly DiversityInc Top list), the company has identified a number of actions it can take to diversify clinical trials. The first centers on communication, an important part of helping people from different cultural backgrounds find their way toward clinical trials, but also in establishing trust.

“There’s a history of researchers not doing a good job of making it clear to patients or participants exactly what we want them to do,” Dr. Joseph Ravenell, member of the Abbott Medical Advisory Board on Diversity, said. “Once we reach them, we must communicate clearly exactly what we want them to do and the risks and benefits of participating in this trial. Communicating clearly, I think, is the second biggest barrier after figuring out where we go to identify the populations we want in our studies.”

To reach them in the first place, companies have to meet people where they are. Ravenell noted that most public hospitals aren’t participating in clinical trials, meaning those without insurance aren’t being seen at hospitals where clinical trials tend to be.

“Insurance is another proxy for access to clinical trials,” Ravenell said. “If we want to think of a big intervention target for increasing minority participation in clinical trials, we need to think about how we equip the places where many minority patients and people in low-resource settings go, and we need to go to where they’re more likely to be.”

How the company is addressing this was outlined in a case study published on Abbott’s website in late 2021. Life-BTK was a clinical trial which studied a new treatment for severe disease in arteries, a condition known as Peripheral Artery Disease (PAD). Patients with PAD experience narrow or blocked blood vessels, particularly in the legs, which can lead to amputation. It’s a condition disproportionately found in Native American, African American and Hispanic patients.

Abbott set about addressing the most common barriers by first partnering with physicians these communities trusted. If the physicians didn’t have experience participating in clinical trials, Abbott provided training and guidance around how to help its patients apply and enroll.

The next step was to reach people with materials that could help them understand the benefit of the trial to not only the patient, but the broader population, and do it in a way that made sense to the patient. Ditching scientific jargon for more plainly spoken terms and in non-English speaking patients, native languages helped create a better connection and establish the trust and understanding needed to ensure enrollment.

“When we choose to communicate only in English, we miss a whole segment of the population,” Jennifer Jones-McMeans, Divisional Vice President of Global Clinical Affairs at Abbott, said. “Something as simple as multilingual educational materials could open the possibility of increasing enrollment of patients whose mother tongue might be, for example, Spanish, Vietnamese or Hindi.”

Finally, Abbott sought out clinical care centers in communities where clinical trials had never taken place before, prioritizing facilities with a diverse staff as well as a diverse patient population.

Building on the Efforts of the Past

These efforts aren’t the first to build diversity into scientific research. You may have heard the term “precision medicine” in the past, which refers to a more personalized model of care that accounts for demographics, lifestyle and social determinants of health to provide interventions or treatments tailored to individual patients.

Efforts to promote precision medicine have been stood up by the National Institutes of Health and date back to the Obama administration’s Precision Medicine Initiative.

Dr. Elizabeth Cohn, Rudin Professor of Community Health at Hunter College, City University of New York, was an Obama White House Champion of Change in Precision Medicine and Health Equity. She is now involved in what the PMI has become under the Biden Administration, the All of Us study, an effort she refers to as the lesser-known sibling of the Biden Moonshot Initiative.

“The All of Us study was designed collaboratively between the Obama White House and the National Institutes of Health to fill in that gap that we were afraid we would advance through precision medicine, where we would advance medicine for some but not for everyone and by doing that, we would create a larger gap than we originally had,” Cohn said at the Center for Healthcare and Innovation’s recent Diversity, Inclusion, & Health Equity Symposium – East Coast event in New York City. “The All of Us research program has 80% underrepresented minorities. We’re 585,000 on our way to a million-person longitudinal cohort of 10 years or more.”

The study includes 80% underrepresented minorities and is 50% multiracial and ethnic. The rest of the 30% is rural populations and gender and sexual minorities, including people who are transgender, have a disability and other understudied populations. One of the key components driving All of Us is the complete lack of inclusion criteria.

“This is part of a work that thinks about what’s it’s like for real world research. A patient with hypertension may not be eligible for a study. Something we wanted to study was how people are in the real world,” Cohn said. “There’s no inclusion criteria, anybody can join, but it is really designed for racial and ethnic and other underrepresented minorities. We do skew in that direction, so for that reason, we recruit from federally qualified hospitals, Walgreens, if you live in a rural area can recruit you, and it is not a research study that does anything, it’s a platform for all of you. Every single person in this room. It’s a platform that allows you to do research that will close the gap in minority health. The project will fail if we don’t use it to close the gap, so I have to ask everyone to please go on and register because we need you to help. We have built this for you in hopes that you will come.”

Learn how we helped 300+ top brands turn inclusion into business impact
Let have a chat!

You can reach us at 973.494.0506 or send us an email, or fill out the form below, and we’ll be in touch to assist you.

* indicates a required field

What Can We Help You With?*