LAS VEGAS – Clinical trials of treatments for(IBD) have disproportionately enrolled White people, researchers say.
These skewed demographics could result in researchers overlooking differences in how the disease and its treatments might affect other racial and ethnic groups, said Jellyana Peraza, MD, a chief resident at Albert Einstein College of Medicine, New York.
“The only way we can determine that therapies work differently in different populations is by including those populations in these clinical trials,” she said in an interview. “We think that diversity should be present, and that will answer some questions about the pathogenesis of the disease in general.”
Dr. Peraza presented the findings at the annual meeting of the American College of Gastroenterology.
Previous studies have found that, in trials of other conditions, such as cancer and cardiovascular disease, White people have been disproportionately represented. However, little research has been conducted regarding race and ethnicity in IBD trials.
To fill that gap, Dr. Peraza and colleagues analyzed data from completed trials through the U.S. National Library of Medicine’s registry, ClinicalTrials.gov, for the period from 2000 to 2020.
They found 22 trials conducted exclusively in the United States and 56 conducted in other countries that reported the race or ethnicity of participants; 54 trials did not include this information.
With regard to the prevalence of IBD in White people and Asian people, these populations were overrepresented in U.S. clinical trials. All other groups were underrepresented.
The researchers calculated the odds ratio of being included in an IBD clinical trial for each group. Compared with White people, all the other groups were less likely to be included except for Asian people, who were 85% more likely to be included. These ORs were all statistically significant (P < .03) except for Hispanic people (OR, 0.81; 95% confidence interval, 0.65-1.01; P = .06).
It’s not clear why Asian people are overrepresented, Dr. Peraza said. “Honestly, that was kind of surprising for us. We initially thought that could be related to where these studies were conducted, for example, if some of them were conducted on the West Coast, where maybe more Asian communities are located. However, we didn’t find any specific association between location and Asian representation.”
IBD is more prevalent among White people, although its prevalence is increasing among other groups, Dr. Peraza said. However, that is not reflected in the trials. In an analysis of data in 5-year increments, the researchers found that the participation of White and Hispanic people in IBD trials had not changed much, whereas the participation of Black people had declined, and the participation of Asian and Native American people had increased.
On the basis of work of other researchers, Dr. Peraza said that people of color are as willing to participate in trials as White people. “There is not so much a mistrust as a lack of education and a lack of access to the tertiary centers or the centers where these studies are conducted,” she said.
Clinical trial investigators should recruit more participants from community centers, and health care practitioners should talk about the trials with people in underrepresented groups, she said. “They should have the conversation with their patients about how these clinical trials can benefit the evolution of their diseases.”
One research center that is working hard to diversify its IBD trials is the Ohio State University IBD Center, Columbus, said Anita Afzali, MD, its medical director.
“We have a great team that works actively on the recruitment of all patients,” she said in an interview. “Oftentimes, it just takes a little bit of education and spending time with the patient on discussing what the options are for them.”
Some research indicates that Black people with IBD are more likely to have fistulizing disease, Dr. Afzali said. “However, it doesn’t come so much of their differences in phenotype that we’re seeing but more so the differences in access to care and getting the appropriate therapy in a timely way.”
Dr. Peraza and Dr. Afzali disclosed no relevant financial relationships.
AGA applauds researchers who are working to raise our awareness of health disparities in digestive diseases. AGA is committed to addressing this important societal issue head on. Learn more about AGA’s commitment through the AGA Equity Project.
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