464 - Factors Associated with Enrollment of Racial and Ethnic Minority Children in Pediatric Asthma Clinical Trials

Poster Number: 464
Publication Number: 464.361

Background: Published studies show mixed results on the representation of historically marginalized racial and ethnic groups in clinical trials. There remains limited data on enrollment trends in pediatric clinical trials.

Objective: To evaluate the representation of racial and ethnic minority children in US-based pediatric asthma clinical trials and identify trial characteristics associated with representation of minority children.

Design/Methods: We performed a cross-sectional review of US-based pediatric ( < 18 years) interventional asthma trials, which were conducted from 2008 to 2022 and had results reported in ClinicalTrials.gov. Outcomes of interest were: (1) the proportion of trials reporting race and ethnicity of enrollees, (2) disparities in the enrollment of racial and ethnic minority children, compared with the US asthma prevalence in each group, and (3) trial attributes associated with participation. Disparities in representation were assessed using the enrollment incidence disparity (EID) measure, quantified by the difference between trial participant make-up and US disease prevalence by race or ethnicity. Beta regression with logit link was used to evaluate the association between enrollment and trial attributes.

Results: Of the 210 trials, 171 (81.4%) and 107 (51.0%) reported on race and ethnicity, respectively. The majority of participants were White (64.7%) and non-Hispanic (95.1%) (Table 1). Black, Asian, American Indian and Alaska Native, and Native Hawaiian/Pacific Islander made up 13.8%, 7.8%, 1.9%, and 0.1%, respectively. Compared to their contribution to disease prevalence, Black and White children were enrolled in expected proportions, while children of other racial and ethnic groups were underrepresented (Figure 1). Hispanic children were most underrepresented (EID: -9.76, 95% CI -11.77, -0.77). Black children were less likely to be enrolled in drug or device trials (beta=-1.6; 95% CI -2.4, -0.7, Figure 2), while White children were more likely to participate (beta=1.8; 95% CI 1.0, 2.6). Hispanic children were more likely to be enrolled in trials with government funding (beta=1.0; 95% CI 0.1, 2.0) and less likely to be enrolled in early phase trials (beta=-1.8; 95% CI -2.4, -1.2).

Conclusion(s): Participant race and ethnicity were incompletely reported for pediatric asthma clinical trials. With the exception of Black children, racial and ethnic minority children were underrepresented. Careful attention to trial characteristics as part of study design may help promote inclusion of racial and ethnic minority children in future pediatric asthma trials.