The Executive Suite: Diversity in research: How to improve representation in clinical trials

Healthcare leaders say researchers and institutions must make greater efforts to include more women and members of minority groups in medical research.

At the American Heart Association Scientific Sessions in Philadelphia, leaders and researchers said diversity isn’t a talking point or an aspirational goal.

Nakela L. Cook, executive director of the Patient-Centered Outcomes Research Institute, said the lack of diversity leads to less effective research, since women and individuals of color may not respond to diseases - or therapies - in the same way.

“If these populations are not fully represented, it will affect fact the applicability of the findings," Cook said.

During a spirited session, they outlined some strategies and principles that healthcare organizations, academic institutions and researchers should consider to get more diversity in clinical trials. Here are some of their key takeaways.

Leadership matters

Speakers noted that the participants in clinical trial often end up being white males because white men are leading the committees overseeing research.

It’s time to get more women in leadership positions, said Shelly Zieroth, a heart failure cardiologist at St. Boniface Hospital in Winnipeg, Manitoba. In an analysis of cardiovascular studies, women accounted for only 11% of the leadership committee members, according to a research letter published by Jama Internal Medicine in 2020.

“Here’s one I feel strongly about: including more women in trial leadership,” Zieroth said.

Eldrin F. Lewis, the chief of the division of cardiovascular medicine at Stanford Medicine, stressed the importance of training researchers from underrepresented groups to lead trials.

“We need to extend pipeline training and training and the diversity of training and leadership will be paramount,” Lewis said.

Explain research

Most members of the public don’t understand clinical research or how trials work, said Ileana Piña, a professor of medicine at Thomas Jefferson University and the quality officer for the heart and vascular service line.

In reaching out to the Latino community, she highlighted the need to appeal to their generosity and willingness to help others. For older Latino patients, Piña said researchers should also welcome their family members into the discussion to explain the trials and answer their questions.

Piña also pointed out banners and signs at Ohio State University talking in plain language about how their medical research helps patients, and directly encourages visitors to ask about clinical trials and how they can get involved. More institutions should follow that approach, she said.

Lewis also suggested that printed materials explaining trials to potential participants should be in simple language, such as an 8th-grade reading level, so they can be easily understood.

Go into the community

Several speakers talked about the idea of going out into the communities to find people from diverse walks of life.

Cook talked about the need to get input from community members and leaders in reaching those from underrepresented groups. Researchers should bring “diverse perspectives and the lived experience to the table to really understand how we best include populations in our clinical research enterprise.”

Researchers should invite the perspective of patients early and also work to get patients to weigh in on the structure of the trials, Piña said.

“You want to hear what they're thinking and it's very different than our concept of what they're thinking,” Piña said.

Researchers also should have interpreters available to communicate with individuals who don’t speak English or are more comfortable using another language.

Build lasting relationships

Researchers should enlist communities to help design clinical trials and be transparent in reporting the results to communities, Cook said. This offers the chance for communities to have a sense of ownership of a trial and “the feeling that it is theirs,” she said.

An audience member noted that often, a researcher will conduct a study and then doesn’t return to the community. Cook urged researchers to build lasting relationships with communities to expand opportunities for research.

“It's not always about the study you're currently conducting,” Cook said. “It may be about the next one, the next one that comes after, and so having that kind of stewardship community stewardship approach, I think, is incredibly important.”

Reaching out to women

Women typically take on the bulk of family responsibilities, including caring for children, even as they work outside the home. Women faced extra challenges during the height of the pandemic, when many children were getting their education remotely. ‘Women had to work, take care of kids and teach them school at the same time,” Zieorth noted.

Researchers need to consider those responsibilities and find ways to make it manageable for women to participate in studies.

Women are more likely to discontinue study drugs than men, and that’s another area where researchers should ask more questions.

“Let’s document why, and figure out how we can overcome that barrier,” Zieroth said. “Is it societal obligations? Is a biological reason behind this? Is a financial reason behind this?”

More diverse sites

Institutions need to cast a wider net and utilize more diverse sites for research.

“We go back to the same investigative sites,” Lewis said. “And a lot of these sites don't actually have people who are self-described Black. And then we expect to see an enrollment that changes.”

He added, “We need to diversify the sites, have language-appropriate and cultural literacy and sensitivity, as well as community engagement, which is overarching, and diversify the investigators.”

Institutional strategies

Organizations should ensure that younger researchers and staff have fair opportunity to funding, networking and advancement opportunities, Lewis said.

Institutions should offer guidance on improving diversity in clinical trials and report representative trial enrollment as a metric, he added.

Organizations could also require grant applications to address the diversity of participants and researchers involved in trials, he said.