Abstract
BACKGROUND: Underrepresentation of racial and ethnic groups in clinical trials can limit generalizability of research findings and equitable access to treatment. This study evaluates racial and ethnic representation of youth in US-based interventional trials on childhood type 1 diabetes (T1D). METHODS: This cross-sectional study examined interventional trials of T1D conducted in the US and registered on ClinicalTrials.gov. Trials were included if completed as of June 6, 2023, began between years 2010 and 2022, and exclusively enrolled youth ≤19 years old. We assessed representation of racial and ethnic groups in T1D trials, estimated using the enrollment-prevalence difference (EPD). RESULTS: A total of 106 trials were eligible for inclusion. Of those eligible, 62 (58 %) trials reported participant race or ethnicity and were included in the analyses. Significant disparities in enrollment were observed for American Indian/Alaska Native, Asian/Pacific Islander, Black, and Hispanic youth compared to their respective contribution to disease burden among youth in the US. Disparities in trial enrollment were greatest for Black (EPD, -10.2; 95 % confidence interval [CI], -14.4 to -7.9) and Hispanic (EPD, -7.7; 95 % CI, -12.6 to -4.8) youth. EPDs of trials conducted prior to year 2017 did not differ significantly from those conducted as of year 2017. CONCLUSIONS: Historically marginalized racial and ethnic youth were underrepresented in T1D trials. Strategies to improve recruitment of these populations are needed to reduce inequities in diabetes treatment and outcomes.