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Enrollment of underserved racial and ethnic populations in pediatric asthma clinical trials
Alexandra T Geanacopoulos1, Ann Chen Wu2, Florence T Bourgeois3,4
1Division of Emergency Medicine, Boston Children's Hospital, Boston, Mass.
Insights
Enrollment of children in US pediatric asthma trials generally reflects disease burden, but American Indian/Alaska Native and Asian children remain underrepresented. Efforts are needed to improve inclusion of these groups in clinical research.
Area of Science:
- Pediatric clinical trial enrollment
- Health disparities research
- Asthma epidemiology
Background:
- Limited data exist on enrollment trends for historically underserved racial and ethnic children in clinical trials.
- Assessing representation in pediatric asthma clinical trials is crucial for understanding health equity.
Purpose of the Study:
- To evaluate the documentation and representation of race and ethnicity in United States-based pediatric asthma clinical trials.
- To identify enrollment disparities among different racial and ethnic groups in pediatric asthma research.
Main Methods:
- Cross-sectional study of US interventional pediatric asthma trials registered on ClinicalTrials.gov (2008-2022).
- Assessed enrollment disparities using the enrollment prevalence difference (EPD) metric, comparing participant enrollment proportions to US asthma prevalence by race and ethnicity.
Main Results:
- Most trials reported race and ethnicity data (79.2% and 53.7%, respectively).
- While Black, Hispanic, multiracial, and White children were enrolled proportionally, American Indian/Alaska Native and Asian children were underrepresented (EPD = -1 and -3, respectively).
- Fewer Black children were enrolled in drug/device trials, and fewer Hispanic children were in early-phase trials.
Conclusions:
- Pediatric asthma trial enrollment in the US largely aligns with disease demographics for most groups.
- Significant underrepresentation of American Indian/Alaska Native and Asian children necessitates targeted inclusion strategies.
- Future research must prioritize equitable enrollment to address health disparities in pediatric asthma.
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.
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