Nonwhite individuals appear underrepresented in food allergy clinical trials
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Key takeaways:
- 45.31% of food allergy trials did not report race or ethnicity.
- White and Asian individuals were overrepresented in trial populations.
- Hispanic and Black individuals were underrepresented in trials.
ANAHEIM, Calif. — White and Asian individuals appeared overrepresented in food allergy clinical trials, despite that the burden of food allergy tends to be higher among historically underrepresented groups, according to study results.
“Recent evidence suggests that the prevalence and burden of food allergy are higher in racial and ethnic minorities compared to white, non-Hispanic counterparts,” Angela Zhang, BS, clinical research coordinator in the division of allergy and immunology at Boston Children's Hospital, told Healio. “In particular, Black and Hispanic patients were underrepresented compared to their proportion of the food allergy population, whereas Asian patients were overrepresented. Due to a lack of data on Native Hawaiian/Pacific Islander and American Indian/Native American populations, we were unable to compare enrollment rates to the incidence of food allergy in these groups.”
Specifically, during her presentation at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting, Zhang referenced data published this year in JAMA Network Open in which Jiang and colleagues found that the prevalence of convincing food allergies was 10.5% among Asian Individuals, 10.6% among Black individuals, 10.6% among Hispanic or Latino individuals and 13.4% among individuals of multiple or other race/ethnicity, compared with 9.5% among white individuals.
However, this study not only showed a greater prevalence of food allergy among these groups, but greater use of epinephrine autoinjector prescriptions, ED visits, rates of severe allergic reactions and prevalence of multiple food allergies also indicates a greater food allergy burden as well, Zhang said.
“If you're Black, you are more than one and a half times more likely than somebody who is white to visit the emergency room because of your food allergy,” she said during her presentation. “And if you're Hispanic, you’re about two times more likely.”
It’s these disparities that prompted Zhang and colleagues to look more closely at the makeup of food allergy clinical trials.
“Diversity and inclusion in the food allergy field is something that our team is particularly passionate about,” she told Healio. “Having witnessed a lack of representation in our own studies, we wanted to see whether our experiences were indicative of a larger trend in food allergy research in the U.S.”
Zhang and colleagues searched clinicaltrials.gov and six prominent medical journals to identify 64 completed interventional food allergy trials that had at least one U.S. site. Of these trials, researchers found that 39.06% of them reported both race and ethnicity, whereas 12.5% reported race only, 3.13% reported ethnicity only and 45.31% reported neither.
When evaluating the approximately 3,400 trial participants in the trials that reported on race, 77.78% were white, which is higher than the 61.6% of white individuals in the general population based on the 2020 U.S. Census. There were also more Asian participants compared with the general population (9.6% vs. 6%), but less representation of American Indians/Native Americans (0.15% vs. 1.1%), Black individuals (3.16% vs. 12.4%), multiracial individuals (3.28% vs. 10.2%), Native Hawaiians/Pacific Islanders (0.09% vs. 0.2%) and other races (2.26% vs. 8.4%), with 3.68% of trial participants having unknown/not reported race.
Regarding the trials that reported on ethnicity, representing about 3,000 participants, 4.41% were Hispanic/Latino compared with 18.7% of the general population. Also, 17.32% had unknown/not reported ethnicity, indicating the inconsistencies with ethnic demographic reporting in these trials, Zhang said.
These results show clear underrepresentation of these groups compared with white individuals, Zhang said.
“A lack of diversity in clinical research not only deprives underrepresented families from the benefits of trial participation, but it can also exacerbate disparities in clinical outcomes for these patient populations,” she told Healio. “Without their participation, drug developers and clinical researchers will not be able to understand how social determinants of health impact the efficacy and dissemination of a new therapy. Moreover, study results cannot be considered generalizable to the entire food allergy population.”
The reason for these disparities is complex, study researcher Rima Rachid, MD, co-director of the Food Allergy Program at Boston Children’s Hospital, associate professor at Harvard Medical School and a Healio Allergy/Asthma Peer Perspective Board Member, told Healio.
“There are concerns for mistrust in the health systems due to prior experiences,” she said. “There are likely a variety of socioeconomic and cultural barriers and systems level factors that may impact families’ ability to participate in trials, including transportation means, language barriers, financial and/or time limitation, inadequate information about trials and clinical research, and possibly other unidentified factors that may prevent or deter minorities from participating in food allergy clinical research.”
Overcoming these differences will require a multi-system approach, according to study researcher Faye Holder-Niles, MD, MPH, medical director of Community Primary Care of the Office of Community Health at Boston Children’s Hospital.
“Increasing the diversity of clinical trials’ staffing and language access available to families will help,” she told Healio. “Additionally, a major step is to work on identifying barriers to access and enrollment from the patient family’s perspective. Our team is working to directly learn from underrepresented patient families on how these factors and challenges may be preventing or limiting their participation in food allergy clinical research. Our team will seek to address these barriers and to deepen the conversation on how to sustainably increase participation, access and equity in clinical trials.”
Other steps Zhang mentioned could be to standardize the reporting of race and ethnicity in trials, collecting patients’ social determinants of health during trial enrollment, and increasing community engagement in clinical trial development.