Diversity in Research Helps Ensure COVID-19 Therapies Benefit the U.S. Population
As researchers studied how to prevent and treat COVID-19 over the past year, they needed to be certain that participants in their studies were representative of the U.S. population – not just people living near study sites. Diversity in clinical research, they knew, increased the chances that new vaccines and therapies would benefit many people – across ages, biological sex and gender affiliations, and racial and ethnic backgrounds. And for many patients considering their options, they are often reassured to know these vaccines or personalized therapies were tested in a wide variety of people of all different backgrounds.
Sairam Parthasarathy, M.D., a professor of medicine at the University of Arizona Health Sciences, is a researcher who looks for ways to diversify clinical trials and explain these benefits to patients. Over the past several months, he and his colleagues strived hard to attract a broad section of the population in Arizona to COVID-19 clinical trials. The strategies they used helped generate noteworthy results: The number of Hispanics/Latinos in the Southwest U.S. as well as American Indian (AI) and Alaska Native (AN) residents living outside of tribal lands who participated in personalized COVID-19 therapeutic trials there were twice the national average. Here, Parthasarathy shares some strategies that have led to that success.
Support inclusive research engagement through a diverse workforce
One way to create long-lasting relationships between researchers and tribal partners is to have a diverse workforce, Parthasarathy said. This allows doctors, nurses, and other health care providers to engage with patients more effectively. For example, an American Indian doctor might better understand why American Indians living on tribal lands had a harder time adopting handwashing practices to reduce risks for COVID-19 than those living in cities where water is often accessible.
“Water is free-flowing, it’s a free spirit,” Parthasarathy said. Many American Indians don’t want to control it. Members of a culturally sensitive workforce might be more understanding and have the cultural awareness and respect to find solutions for tribal communities that don’t have the same relationship with – or access to – resources like water that can help prevent the spread of COVID-19.
Talking to members of American Indian communities about how blood samples are used in research could also help with more effective engagement, Parthasarathy said. Some study participants may be hesitant to provide blood, which helps scientists study COVID-19. If a researcher schedules time to talk about blood collection, this can help ease those fears. However, Parthasarathy noted, it’s also important to respect individuals and tribes who don’t want to participate in studies that involve blood collection and to seek explicit research approval from various regulatory entities.
Partner with AI/AN communities through early and high-level engagement
Parthasarathy noted partnering with AI/AN communities includes thinking about cultural needs and preferences before studies are even designed. This concept, he explained, is like producing a movie.
Typically, movie directors, writers, and producers create scripts, develop plots, and map out scenes – similar to researchers creating studies and protocols. Then, movie directors recruit actors to star in the movie, much like what happens when researchers invite participants to join a clinical trial. But by then, Parthasarathy said, many members of AI communities feel like 80% of the movie has been produced. Now the community is being asked to star in 20% of the scenes. That often doesn’t work, Parthasarathy said. “They want to be there for the whole movie,” he explained. “As any community, they want to be able to create, modify, and adapt the script and storyline to fit their needs.” This, he explained, helps create engaged and empowered stakeholders.
One example of how scientific partnerships, or “coproducing,” can work is playing out at the University of Arizona in Tucson. The university created a new position – a senior vice president for Native American Advancement and Tribal Engagement. Nathan Levi Esquerra, who fills this role, recently kicked off a two-day COVID-19 conference for over 150 attendees. The second day of the virtual conference was dedicated exclusively to Native American research and health topics. Additionally, tribal dancers performed during an intermission, creating a celebratory atmosphere. “Honoring and respecting the community and culture is key,” Parthasarathy said.
He added that the University of Arizona’s Tucson campus is located on the traditional lands of the Tohono O’odham and Pascua Yaqui peoples. “As a land grant institution serving the entire state, we also recognize the homelands of an additional twenty other Tribal Nations on which we work and live,” he explained. “We pay respect to their cultures and histories, as well as to Indigenous Peoples everywhere when we act to foster a diverse and inclusive community.”
“Honoring and respecting the community and culture is key."
Choose the right study locations
When it comes to selecting recruitment sites for clinical studies, it’s “location, location, location,” Parthasarathy explained. You want to be where people are.
Fortunately, many hospitals and medical centers conducted studies near Phoenix and Tucson. Physicians, like Parthasarathy, worked with 200 patients across 47 studies to assess how treatments may help people with moderate to severe COVID-19. Setting up a variety of trial sites made it easy for participants to take part in a study. If patients were sick, they could seek treatment nearby without leaving their towns or neighborhoods.
Parthasarathy and other CEAL researchers continue to look for ways to help residents in other tribal communities access similar treatment after seeking approval from tribal nations. Taking extra steps, such as creating accelerated study protocols, can help. However, Parthasarathy noted that with a condition like COVID-19, “we don’t have the luxury of time” – especially when some communities are 4-7 hours from the closest research site.
Adopt a multilayered approach to engagement
Partnering with AI/AN communities on multiple levels – from doctors meeting families at hospitals to scientists working together to create global solutions – strengthens inclusivity in research, Parthasarathy explained. And he knows from personal experience.
Last year, when he was caring for a patient who was the leader of a native tribe, he made an unintentional faux pas, he recalled. As the attending physician, he met with the patient’s family in the hospital. For another meeting, he was represented by a fellow in training — part of standard medical apprenticeship. However, the patient’s family felt disrespected because the leader of the unit didn’t meet with them. That experience shaped Parthasarathy’s perspective and gave him additional insight about how to engage with patients and study participants on multiple levels – in the hospital, in the community, and as part of evolving COVID-19 research.
As scientists focus on the impact COVID-19 has on multiple organs and systems, such as the heart, lungs, and brain, they also have an opportunity to create new ways to engage with AI communities, Parthasarathy explained. Outreach at every level, early engagement, and appropriate approval by tribal leadership, he said, is critical to strengthening stakeholder-engagement and community-driven research.
Another example of this, Parthasarathy said, is the decision by the leadership of the Tohono O'odham Nation to commit $1 million to ongoing research that supports COVID-19 testing, vaccine education and distribution, and outreach in Arizona. As of early July, vaccination rates among AI/AN communities in Arizona were similar to the national average.
Learn about other CEAL research in Arizona to support members of AI/AN communities, including partnerships with community health workers and a public health campaign designed to strengthen vaccine confidence.