472 - Underrepresentation of Racial/Ethnic Minorities in U.S. Food Allergy Clinical Trials

Poster Number: 472
Publication Number: 472.480

Background: Food Allergy (FA) affects 8% of children and 11% of adults in the U.S. FA incidence is higher in racial and ethnic minorities compared to their White, non-Hispanic counterparts; therefore, it is critical that demographic data of subjects in clinical trials reflect this reality. This topic is of particular interest in the pediatric asthma realm as asthma and food allergy have frequently been found to coexist, have mutual risk factors, and share realities regarding racial and ethnic disparities. 4-8% of pediatric patients with asthma, the most common chronic disease of childhood, also have FA. About half of these patients with both asthma and FA have FA reactions encompassing respiratory symptoms. Improved understanding of FA could also be helpful for better elucidating how food allergens flare asthma symptoms and assist with asthma control.

Objective: We aimed to analyze the racial/ethnic makeup of FA clinical trial participants in the U.S. to assess whether demographic data of subjects in clinical trials are reflective of patients impacted by FA.

Design/Methods: We conducted a search on clinicaltrials.gov and in six prominent medical journals for interventional FA clinical trials with at least one U.S. site. The percentage of clinical trials reporting subject race/ethnicity and the reported racial/ethnic demographic data were recorded.

Results: Of the 64 trials included, 39.1% reported both race and ethnicity, 12.5% reported only race, and 3.1% reported only ethnicity. Where race was reported, 77.8% of participants identified as White, 3.2% as Black or African American, 0.1% as Native Hawaiian or Pacific Islander, 9.6% as Asian or Asian American, 0.2% as American Indian or Native American, 3.3% as Multiracial, 2.3% as Other, and 3.7% were Unknown or Not Reported. Where ethnicity was reported, 4.4% of participants identified as Hispanic or Latino, 78.3% as non-Hispanic or Latino, and 17.3% were Unknown or Not Reported. Overall, Black or African American and Hispanic or Latino participants are underrepresented in FA trials compared to the prevalence of FA in these groups.

Conclusion(s): Racial and ethnic minorities are underrepresented in U.S. FA clinical trials. This reality impedes researchers’ ability to better understand FA, including its relationship with pediatric asthma and triggers of asthma symptoms by food allergens. Efforts to increase diversity of participants in FA clinical trials are essential for generalizability of study results and underscore the importance of engaging underrepresented communities.