Racial and Ethnic Representation in Food Allergen Immunotherapy Trial Participants: A Systematic Review

Area of Science:

• Clinical Trials and Health Services Research
• Food Allergy and Immunology
• Health Equity and Social Justice

Background:

• Clinical trials for food allergy immunotherapy often lack diverse population samples.
• This underrepresentation limits the generalizability of findings and treatments.
• It also contributes to broader social injustices and healthcare inequities.

Purpose of the Study:

• To examine the racial and ethnic distribution of participants in food allergy immunotherapy clinical trials.
• To assess if trial representation aligns with the actual prevalence of food allergy across different demographics.
• To identify disparities in participant inclusion within pediatric food allergy research.

Main Methods:

• Systematic review of food allergy immunotherapy clinical trials published within the last 5 years.
• Data sourced from PubMed and ClinicalTrials.gov using relevant keywords.
• Analysis focused on racial and ethnic demographics, stratified by study site and funding source.

Main Results:

• Of 3689 participants across 26 randomized clinical trials, 72.0% were White, 8.0% Black, 6.0% Asian, and 3.0% Hispanic.
• Significant underrepresentation of Black and Hispanic individuals compared to their food allergy burden.
• Observed variations in diversity based on study location (US vs. non-US) and funding (NIH vs. industry).

Conclusions:

• Food allergy immunotherapy trials demonstrate a lack of racial and ethnic diversity, particularly for Black and Hispanic patients.
• This disparity indicates critical gaps in pediatric clinical trial conduct, affecting broad population treatments.
• Addressing these inequities is crucial for enhancing trial data utility and alleviating public health disparities.