Underrepresentation of Black and Hispanic participants in food allergy immunotherapy trials raises concerns about the relevance of trial results for these populations.
By
Lana Pine
| Published on October 7, 2024
5 min read
A systematic review of 26 food allergy immunotherapy trials revealed that Black and Hispanic participants are underrepresented in research, despite these populations experiencing a higher disease burden. The lack of diversity raises concerns with investigators about the applicability of clinical trial results for these groups and underscores the need for more inclusive research to address public health disparities.
“Food allergies add psychological stress on patients and caregivers and cause increased financial strain from costs of allergen-free foods,” wrote a team of investigators led by Hannah Suffian, MS, an MD Candidate at the University of Missouri Kansas City School of Medicine.
“These burdens are compounded in already marginalized and oppressed populations. As such, food allergy interventions are important to closing disparity gaps and should be expected to include these highly affected populations.”
Food allergies—the most common cause of anaphylaxis in children and adults—currently affect 5.6% of children living in the United States.
To determine whether the representation of different racial and ethnic backgrounds accurately reflects the population of patients with food allergies, investigators performed a database search to identify applicable trials using key terms such as “food hypersensitivity,” “food allergy” and “immunotherapy.” Eligible studies were published within the last five years and recruited children aged from birth to 18 years old (although trials also evaluating adult patients were included as well). In addition to race and ethnicity data, investigators also collected information on the location of the trial and whether it was funded by the National Institutes of Health (NIH) or industry supported.
Results showed the predominant racial demographic group represented in the trials was White (72%). Black and Hispanic individuals were significantly underrepresented (8% and 3%, respectively), despite having higher odds of diagnosis for multiple food allergies compared with White children, compared with the general United States population.
Asian patients made up 6% of the sample, while American Indian and Native American or Pacific Islanders accounted for <1%. Additionally, Black patients made up 10% of pediatric-only trials and only 3% of trials that included both pediatric and adult patients. Conversely, Asian patients accounted for 5% of pediatric-only studies and 9% of combination studies.
Trials funded by both the NIH and non-NIH sources recruited predominantly White participants. Among NIH-funded trials, 76% of patients were White compared with 2% Black patients and 1% Latino patients. Studies not funded by the NIH had slightly more representation, including 11% Black patients, 4% Hispanic patients and 69% White patients.
These findings highlight the gaps in pediatric clinical trials, particularly for treatments that are designed for broad populations with significant race- and ethnic-related disparities. Despite NIH mandates requiring investigators to submit inclusion plans as well as justify reasons for the exclusion of specific patient populations, results indicate these methods may not be effective.
Limitations included the variations across studies regarding the method of determining race and ethnicity, such as self-reported or investigator determined. Therefore, classifications may not have been completely accurate. Additionally, as some studies classified Hispanic ethnicity as both a race and ethnicity group, there is a possibility of misclassification bias.
“Lack of meaningful inclusion of racial and ethnic groups in clinical trials not only limits the potential benefits and effectiveness of health care interventions but also compounds the broader issue of social injustice and inequity in health care,” investigators concluded. “By ensuring diversity and inclusivity in clinical trials, we can both improve health care outcomes and help increase equity and justice in health care.”