Nakela L. Cook, executive director of the Patient-Centered Outcomes Research Institute, talks about improving diversity in clinical trials at the American Heart Association Scientific Sessions Saturday. (Photo: Ron Southwick)
Philadelphia – At a conference filled with presentations of groundbreaking studies, healthcare leaders cited a major problem in medical research.
They point to the lack of diversity in clinical trials. For many years, most study participants have typically been white men, and researchers say the lack of diversity is undercutting the value of many clinical studies.
Researchers spoke passionately – and bluntly – about the problem during a session at the American Heart Association Scientific Sessions in Philadelphia Saturday.
Nakela L. Cook, executive director of the Patient-Centered Outcomes Research Institute, said research that lacks a diverse set of participants is fundamentally flawed. She said the underrepresentation in clinical trials can be seen across medical research, including cardiology.
“Women, children and older adults and racial and ethnic minority populations present differently with their illnesses and certain diseases,” Cook said. “If these populations are not fully represented in clinical trials, it will affect the applicability of the findings to them.”
The lack of diversity brings societal and financial consequences, Cook said. She cited a 2022 report on the lack of diversity in clinical trials from the National Academies of Science, Engineering, and Medicine. The report found that underrepresentation in clinical trials costs hundreds of billions of dollars, in terms of shortened lifespan and years in the labor force. Even a modest improvement in health disparities would produce billions in economic benefits, the report stated.
Moreover, Cook said the lack of representation in research can be a reason why many studies don’t keep enough participants and ultimately fail.
At a time when too many don’t hold the medical establishment in the highest esteem, Cook said the lack of diversity in clinical trials doesn’t help.
“It undermines trust in the clinical research enterprise and the medical establishment,” Cook said.
Shelly Zieroth, a heart failure cardiologist at St. Boniface Hospital in Winnipeg, Manitoba, pointed to the need for more women to be included in health research.
“We know that women are underrepresented in clinical trials, they are under-referred for care, they are under-prescribed, they’re under-tested, under-treated and this differential care matters,” Zieroth said.
Institutions would likely help draw more women into clinical research trials if more women held leadership positions on research committees. “Here’s one I feel pretty strongly about … including more women in trial leadership,” Zieorth said.
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.
Even though heart disease is the leading cause of death among women, many are unaware of the risk, and that’s also affecting the number of women in research. Only about half of women are aware that heart disease is the top killer of women, according to the Centers for Disease Control and Prevention.
“Campaigns like the American Heart Association’s ‘Go Red For Women’ are very important in terms of increasing women’s willingness to participate in clinical trials,” Zieorth said.
She also pointed to the need to develop new strategies to reach out to more women to make them aware of clinical trials.
For one study, researchers planned to reach out on Facebook, but found that it would be better to try and find female participants on Pinterest, which is a very popular social media platform with women, Zieorth said. Researchers could consider similar out-of-the-box approaches to cast a wider net for clinical trials.
“When is the last time you advertised for clinical trial distribution on Pinterest? It might be a very novel opportunity for us to reach more women,” Zieorth said.
Other healthcare leaders talked about the dire need to get more Black and Latino participants in clinical research.
Eldrin F. Lewis, the chief of the division of cardiovascular medicine at Stanford Medicine, said the lack of Black participants has long plagued cardiovascular research. Blacks have been underrepresented in NIH-funded cardiovascular studies, and most studies didn’t articulate plans to enroll more Black participants, according to a 2021 analysis published by the Journal of the American Heart Association.
“If you look at heart failure, which is my area, you can see that there is a paucity of people who are self-described as Black who are randomized in a variety of trials,” Lewis said.
Black individuals face higher risks of mortality from cardiovascular disease. In 2019, Black men were 30% more likely to die from heart disease than non-Hispanic white men, according to federal statistics.
Citing those higher risks, Lewis said there must be dedicated efforts to get more Black residents to take part in clinical trials.
“You have to have an active recruitment,” Lewis said. “You have to develop strategies.”
Ileana Piña, a professor of medicine at Thomas Jefferson University and the quality officer for the heart and vascular service line, talked about the need to enlist more Latino participants in clinical trials.
Older Hispanic residents live with family members, and Piña said they should be included in discussions of entering clinical trials.
“They live with family. That’s a very cultural thing that must be respected,” she said.
Most patients don’t understand randomized clinical trials, so researchers need to explain how they work, Piña said. Researchers should spend time with Hispanic individuals if they want them to help out with research. Institutions also need to make it easy to participate, she said.
Hispanic individuals are very “altruistic” and will take part in trials if researchers make the proper effort.
“They will love being part of clinical trials,” Piña said, adding, “They want to be part of the picture, so let’s include them.”
