abstract
- AIMS: Little is known about the enrollment practice of both Black, Indigenous and People of Color (BIPOC) and females in the US diabetes trials. We aimed to perform a chronological survey to evaluate the enrollment of BIPOC and female participants in the US diabetes randomized controlled trials (RCTs) over the past two decades. METHODS: We searched databases to systematically include the US diabetes RCTs from 2000 January 1st to 2020 December 31st. Primary outcome was the adequate enrollment of both BIPOC and females, defined by the participation to prevalence ratio (PPR) > 0.8. We tested the temporal trend in adequate enrollment over time and used logistic regression analysis to explore the relationship between adequate enrollment and trial characteristics. RESULTS: A total of 69 US diabetes trials were included for analyses, with a median BIPOC and female enrollment percentage of 29.0 % and 45.4 % respectively. There were 22 (31.9 %) trials with adequate enrollment of both BIPOC and females. No significant trend of adequate enrollment percentage of BIPOC and females over time was observed (P = 0.16). Of trial types, those with medication interventions were significantly related to decreased odds of adequate enrollment, when compared to trials with non-drug interventions (odds ratio = 0.29, 95 % confidence interval: 0.11-0.84). CONCLUSIONS: Less than one third of the US diabetes trials adequately enrolled both BIPOC and females over the past two decades, and no temporal improvement in BIPOC and female participant enrollment was observed. These results highlight the need for more endeavors to mitigate inadequate representation regarding BIPOC and female enrollment in diabetes trials.