Background and Aim: Suboptimal representation of race/ethnic minorities in clinical research contributes to critical gaps in our knowledge of diabetes in these populations. We aimed to evaluate the participation of AA and Hisp youth in an observational study in diabetes to assess factors impacting participation.
Methods: We studied 92 participants in the Diabetes Study in Children of Diverse Ethnicity and Race (DISCOVER) that is currently enrolling youth (age 0-yrs) with non-secondary diabetes for collection of data and blood samples. We compared racial/ethnic distribution of actual vs. target enrollment and refusal rates by race/ethnicity. We analyzed qualitative data on reasons for study refusal.
Results: The racial/ethnic distribution of participants was 60.9% Hisp, 27.2% AA, 12.0% non-Hispanic white [NHW] and 0% other, vs. enrollment targets of 35.3% Hisp, 31.8% AA, 29.9% NHW and 3% other (p=0.001) . In the population of eligible candidates, 31.1% of the children were Hisp, 18.8% AA, 42.2% NHW and 7.9% other. Refusal rates were 20.0%, 16.7%, 38.9% and 100%, respectively, for Hisp, AA, NHW and other (p=0.072) . Among those who refused, the reasons noted were no interest in research (44.4% overall, 80% in AA youth) , blood draw (29.6% overall, 42.6% in Hisp youth) , no direct benefit to the participant (11.1%) , and being too busy (18.5%) or overwhelmed by the recent diabetes diagnosis (11.1%) . NHW youth cited the first 3 reasons, with similar frequency, for refusal.
Conclusions: Refusal rates were not elevated in AA and Hisp children compared with NHW. Actual enrollment was statistically different from the target, with over-representation of Hisp youth and underrepresentation of NHW youth. Facilitators of racial/ethnic minority participation in research studies may include diverse racial/ethnic distribution in the population where the study is conducted, a trusted environment, race/ethnicity concordance with research team members, and a minimally invasive study protocol.
M.J. Redondo: Advisory Panel; Provention Bio, Inc. M. Tosur: Advisory Panel; Provention Bio, Inc. A.B. Muir: None. S. Iftekhar: None. S. Deen: None. D.J. Perry: None. D.H. Glueck: None. K. Vehik: None. R.A. Oram: Consultant; Janssen Research & Development, LLC. Research Support; Randox R & D. W. Hagopian: Research Support; Janssen Research & Development, LLC. D. Dabelea: None. M.A. Atkinson: None.
NIH NIDDK RDK124395