Moderna Executive on Advancing Health Equity in Medical Research and What All Businesses Can Learn

Three strategies Moderna tapped to improve access to medicines and diversity representation in clinical trials:

• Building partnerships and recognizing that you can’t go it alone: “We need to stand on the shoulders of organizations that have already engendered trust in their communities,” said Jameka Hill, Senior Director, Clinical Trial Health Equity, at Moderna.
• Being transparent about your diversity recruitment goals so you can be held accountable: “That gives people confidence that they can trust in the data and [our] products,” Hill said.
• Doing what it takes to improve access to marginalized and disadvantaged communities: Moderna partners with organizations that send mobile health clinics to perform routine checkups and share important clinical trials information.

Jameka Hill joined Moderna smack dab in the middle of a firestorm: It was 2020. COVID-19 was taking a devastating toll and the race was on to develop a safe and effective vaccine.

As Senior Director, Clinical Trial Health Equity at the pharmaceutical company, Hill had to ensure diversity of population representation in the clinical trials. Fortunately, she had been preparing for this moment for a long time. For over 20 years, Hill has focused on improving access to clinical trials for women, older adults, racial and ethnic minority groups, patients with rare disease, and vulnerable populations including pregnant women, infants, and children.

Thanks to efforts from Hill and colleagues, the Moderna Phase 3 study of the vaccine, called the COVE (Coronavirus Efficacy) study, reflected the racial and ethnic makeup of the United States. The 30,406 participants included 6,247 Hispanics (20%) and 3,114 African Americans (10%). Those percentages closely mirror the country’s racial makeup: 18% and 13%, respectively.

The necessity of diversity representation: Catering to ‘the population that’s going to use the product’

While diversity representation is key across the board, it’s especially crucial in pharmaceutical development because people may react differently to certain medicines and vaccines because of their age, sex, race, or ethnicity.

So, a medicine that shows promise only after testing on a homogenous clinical trial population may not work on the population as a whole.

Clinical trials, which usually run through four phases, have historically underrepresented diverse populations, Hill pointed out to CO―. But “Moderna is really focused on ensuring that our vaccines and therapies are safe right from the very beginning of phase one,” she said.

“Our goal from a scientific imperative is to ensure that at each of [the] important milestones along the drug development process, we have the data to show with confidence, that it’s actually safe, effective, and the dosing is correct for the population that’s going to use the product,” Hill said.

Moderna qualifies a clinical trial as diverse when:

• 37% of the sample population within the U.S. are persons of color;
• 50% are female assigned at birth; and
• There’s a balance across age cohorts.

Moderna has now had 18 clinical trials that have been an estimated 40% diverse.

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The challenges of ensuring diversity in trials: Enlisting physicians who look like the communities they serve to ‘build trust’

Recruiting diverse individuals for trials is easier said than done. First, “there’s a lack of awareness where people just don’t know about the clinical trials,” Hill said. Logistical barriers — childcare, distance to travel — are also a problem. “Even if we’re able to [tackle these], we still have to address the long-standing historical mistrust in communities,” Hill said. “Research hasn’t always been ethical and it’s incumbent upon us to not forget it but also share what we’re doing to help address it, so it doesn’t happen again,” she said.

The widespread dissemination of misinformation on social media is another challenge. “One of the things that we have to continue to do is get more physicians to participate in research who look like the community that they’re going to be serving because that will help to negate some of the misinformation that’s out there,” Hill said. Such an approach helps build trust.

Understanding that geographical barriers might thwart access to medicines and participation in trials, Moderna is using mobile care centers to reach remote communities and people who might have challenges with transportation.

Through partnerships like the one with healthcare company CVS Health, Moderna has been able to share information about its clinical trials.

Moderna also nurtures partnerships with national medical organizations like the National Organization of Rare Disorders (NORD) and works extensively with a variety of other national and community patient-focused organizations.

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What health equity looks like: Share understandable data with people so they can make informed decisions

“Health equity at Moderna means that we want everyone, regardless of background, to have access to the promising medicines of tomorrow,” Hill said. About a quarter of all doses of Moderna’s COVID-19 vaccine delivered in 2021 went to low- and middle-income countries.

“One of the things we focus on is ensuring that we get the right information in the hands of the people we serve. How do we get them to be health-literate?” Hill said, “It’s about meeting people where they are so they understand information and it’s easily digestible so they can actually utilize it to empower themselves and make informed decisions,” she added.

Transparency is also vital, Hill said. “We want our research sites as well as the public at large to be aware of what we’re striving for. It’s like when you play a game – if you don’t know what the score is, or what it needs to be, it’s hard to make adjustments in order to get there,” she added.

Removing barriers to representation in clinical research is an ongoing commitment at Moderna, applicable to all medicines the company develops now and in the future. “We don’t see trial diversity and health equity as a [separate] initiative,” Hill said, “it’s just completely folded into our values as an organization.”

By paying attention to diversity representation, Moderna has shown that it’s possible to bring a product to market quickly and safely through a drug development process that is safe — and inclusive, Hill said.

When Hill had premature twins a few years ago, “all of a sudden I was squarely in the middle of myself being somebody who was historically underrepresented,” she said. “I have been given the opportunity of a lifetime to support Moderna and our efforts to ensure representation, [health equity, and access].”

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