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. 2024 Jul 26;3(4):100315.
doi: 10.1016/j.jacig.2024.100315. eCollection 2024 Nov.

Enrollment of underserved racial and ethnic populations in pediatric asthma clinical trials

Alexandra T Geanacopoulos  1 , Ann Chen Wu  2 , Florence T Bourgeois  3   4 , Alon Peltz  5 , Ryan Walsh  2 , Amy Han  2 , Mei-Sing Ong  2
Affiliations

Enrollment of underserved racial and ethnic populations in pediatric asthma clinical trials

Alexandra T Geanacopoulos et al. J Allergy Clin Immunol Glob. .

Abstract

Background: The existing data on enrollment trends of historically underserved racial and ethnic children in clinical trials are limited.

Objective: We sought to evaluate documentation and representation of race and ethnicity in pediatric asthma clinical trials in the United States.

Methods: This is a cross-sectional study of United States-based interventional trials studying pediatric asthma that were completed between 2008 and 2022 and registered on ClinicalTrials.gov. Enrollment disparities were assessed by using the measure enrollment prevalence difference (EPD) (defined as the median difference between the proportion of participants enrolled and asthma prevalence in the US population by race and ethnicity).

Results: Of the 67 trials reviewed, 53 (79.2%) and 36 (53.7%) reported on race and ethnicity at ClinicalTrials.gov, respectively. Most participants were White (39.1%), Black (37.1%), or non-Hispanic (66.1%). Black, Hispanic, multiracial, and White children were enrolled in the expected proportions based on their contribution to asthma burden. However, American Indian or Alaska Native (AI/AN) (EPD = -1 [95% CI = -1 to -1]) and Asian children (EPD = -3 [95% CI = -3 to -3]) were underrepresented relative to disease burden in these respective groups. Fewer Black children were enrolled in drug or device trials (β = -0.80 [95% CI = -1.60 to -0.01]) than in other trials. Fewer Hispanic children were enrolled in early-phase than late-phase trials (β = -2.42 [95% CI = -3.66 to -1.19]).

Conclusions: Enrollment in pediatric asthma trials conducted in the United States was commensurate with the demographics of children affected by asthma for most racial and ethnic groups, but American Indian or Alaska Native and Asian children were underrepresented. Concerted efforts are needed to promote inclusion of these underserved groups in future trials.

Keywords: Asthma; disparities; pediatric clinical trials.

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Conflict of interest statement

Supported by the 10.13039/100000133Agency for Healthcare Research and Quality (grant 2T32HS000063-30 [to A.T.G.]) and the 10.13039/100006545National Institute on Minority Health and Health Disparities (grant R21MD016984 [to M.O.]). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The funders were not involved in the design, analysis, or manuscript development. Disclosure of potential conflict of interest: The authors declare that they have no relevant conflicts of interest.

Figures

Fig 1
Fig 1
Flow diagram for selection of study trials
Fig 2
Fig 2
Median (95% CI) EPD by race and ethnicity. A wider CI indicates that trial enrollment varied widely. A narrow CI indicates that a group was consistently underrepresented or overrepresented in all trials. Native Hawaiian or Pacific Islander children were excluded from analysis, as we were not able to find reliable data for US pediatric asthma prevalence.
Fig 3
Fig 3
Multivariate analyses of trial attributes associated with enrollment for a givenracial and ethnic group. The analyses included only attributes that attained at values of P less than .2 in univariate analyses (see Table E2).
See this image and copyright information in PMC

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