Document Type

Article

Publication Date

9-3-2024

Identifier

DOI: 10.1001/jamanetworkopen.2024.32710; PMCID: PMC11406388

Abstract

IMPORTANCE: The lack of inclusion of diverse population samples in food allergy immunotherapy clinical trials not only leads to decreased applicability to the general population in terms of results and treatments but can also be seen as a broader social injustice contributing to inequity within the health care system.

OBJECTIVES: To investigate the racial and ethnic distribution of participants included in food allergy immunotherapy clinical trials, and determine whether the racial and ethnic representation in trials accurately reflects the patients who experience food allergy.

EVIDENCE REVIEW: Data were collected from articles found on PubMed and ClinicalTrials.gov using key terms of food hypersensitivity, food allergy, and immunotherapy, while also incorporating specific criteria such as clinical trials conducted within the last 5 years with children aged from birth to 18 years old. Articles were selected based on their relevance to the research question. Main outcomes were totals and percentages of trial participants by race and ethnicity, stratified by pediatric trials, site of study, and National Institutes of Health funding.

FINDINGS: Thirty-five articles were initially identified, of which 34 were classified as human clinical trials. Of these trials, 26 met criteria of an original randomized clinical trial and included racial and ethnic demographics for analysis in the study. Among trials included, the majority of the 3689 participants identified as White (2640 participants [72.0%]), followed by Black or African American (293 participants [8.0%]), Asian (239 participants [6.0%]), multiple races or other (210 participants [6.0%]), Hispanic or Latino (96 participants [3.0%]), American Indian (3 participants [ < 1.0%]), and Native American or Pacific Islander (3 participants [ < 1.0%]). We observed differences in racial and ethnic inclusion by study site (US vs external to US) and funding support (National Institutes of Health vs industry or other non-National Institutes of Health sources).

CONCLUSIONS AND RELEVANCE: In this systematic review of racial and ethnic diversity in food allergy immunotherapy trials, there was a lack of diversity relative to the overall food allergy burden among Black and Hispanic patients, indicating important gaps in the conduct of pediatric clinical trials, especially for treatments that are meant for use in broad populations where significant race- and ethnicity-related disparities exist. Working to correct this disparity will not only increase the usefulness of future clinical trial data but can further assist in alleviating public health inequities.

Journal Title

JAMA Netw Open

Volume

7

Issue

9

First Page

2432710

Last Page

2432710

MeSH Keywords

Humans; Food Hypersensitivity; Child; Ethnicity; Desensitization, Immunologic; Adolescent; Child, Preschool; Clinical Trials as Topic; Racial Groups; Male; United States; Female; Infant

Keywords

Food Hypersensitivity; Ethnicity; Immunologic Desensitization; Clinical Trials as Topic; Racial Groups; United States

Comments

This is an open access article distributed under the terms of the CC-BY license, which permits unrestricted use, distribution, and reproduction in any medium. You are not required to obtain permission to reuse this article content, provided that you credit the author and journal.

Publisher's Link: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2823521

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