Study Identifies Lack of Diversity in Food Allergy Immunotherapy Research

There is a lack of diversity in food allergy immunotherapy research relative to overall allergy burden among Black and Hispanic patients, new findings suggest, indicating gaps in the pediatric clinical trial conduct.¹

These data resulted from new research published in JAMA and authored in part by Hannah Suffian, MS, from the University of Missouri-Kansas City School of Medicine. Suffian et al. wrote that previous research had also pointed to a lack of inclusion among clinical studies looking at monoclonal antibody therapies in children, adding that they suspect similar underrepresentation may be seen within food allergy research.²

“In the study reported here, we aimed to describe the racial and ethnic distribution of participants included in food allergy immunotherapy trials based on our hypothesis that disparities exist in the racial and ethnic representation among food allergy clinical trials,” Suffian and colleagues wrote.¹

Trial Design

The research team identified trials for inclusion in their analysis by carrying out a search of PubMed. The team also received assistance from a professional librarian found at the Missouri-Kansas City School of Medicine.

They specifically looked into clinical research which had been conducted within the prior 5 - 10 year timeframe. Throughout their search of the database, the investigators used key terms and phrases including desensitization, food hypersensitivity, immunotherapy, and food allergy.

The team’s criteria for study inclusion specifically targeted research which had involved children from birth to 18 years old. They also implemented a similar search method which was carried out using the ClinicalTrials.gov website, with terms such as immunotherapy and desensitization for food allergies being searched and with studies including children from birth to the age of 17.

Despite the fact that the research team’s main focus was on those in pediatric populations, research which was shown to include adult participants was also incorporated into their search. The investigators’ search itself was done in July 2022, with the team gathering articles that had been identified based on their inclusion of data on race and ethnicity, general relevance, and status as randomized clinical trials.

The study subjects were categorized, for the purposes of data collection and analysis, by ethnicity, racial group, trial region (inside or outside the US), age (divided into cohorts of 0-18 years and 19 years and older), and whether the research had been NIH-funded or supported by industry. Frequencies of subject race and ethnicity were later calculated by the investigators using trial location, age group, and source of funding, with data from either the included studies or ClinicalTrials.gov.

Findings

The investigators reported that there had been 35 articles they initially found in their search, adding that 34 of these studies had been classified as human clinical trials. Among this list, the aforementioned criteria determined by the team were met by 26.

The research team noted that majorities of the 3689 study subjects within all of these studies were found to be White. The team noted that they comprised 72% of their sample, with a total of 2640 participants.

The research team noted that 3% (96) had been labeled as Hispanic or Latino, 6% (210) were shown to identify as multi-racial or other categories, and less than 1% (3) were noted as being either American Indian or Native American/Pacific Islander. The investigators also found that 8% of their sample had been Black or African American subjects (293), adding that 6% had been labeled as of Asian descent (239).

In the inclusion of racial and ethnic group variations were highlighted depending on the location of research (within the US or internationally). The team also reported that variations existed based on funding sources, with differences between National Institutes of Health versus industry or other non-NIH sources.

Representation of racial or ethnic groups within NIH- vs non-NIH funded studies was found by the investigators to include largely White individuals. The team noted less representation from Hispanic and Black participants had been seen in such research versus non-NIH funded trials.

“Limitations of our study include that the method of race and ethnicity determination (eg, self-report vs investigator determined) varied across studies and was not always discussed in the papers included,” they explained. “Therefore, race and ethnicity classification may not have been always accurate.”

References

1. ^{Suffian H, Pandya A, Davidson L, Staggs V, Jones BL. Racial and Ethnic Representation in Food Allergen Immunotherapy Trial Participants: A Systematic Review. JAMA Netw Open. 2024;7(9):e2432710. doi:10.1001/jamanetworkopen.2024.32710.}
2. ^{Kesh S, Jones BL. Step-up therapy in Black patients with asthma. N Engl J Med. 2020;382(4):390. doi:10.1056/NEJMc1915819.}