J Crohns Colitis. 2023 Aug 16:jjad138. doi: 10.1093/ecco-jcc/jjad138. Online ahead of print.
ABSTRACT
BACKGROUND & AIMS: Randomized controlled trials historically underrepresent marginalized racial and ethnic populations. As incidence and prevalence of Crohn’s Disease in these groups rises, it is important to characterize their inclusion in randomized controlled trials on first-line and pipe-line medications.
METHODS: PubMed was searched systematically for randomized controlled trials of biologic and small molecule inhibitor (SMI) medications with a primary outcome related to efficacy following PRISMA guidelines. We used descriptive statistics to summarize demographic variables and meta-regression analyses to estimate temporal trends in racial inclusion.
RESULTS: More than a half of trials did not report any racial/ethnic demographics (53.7%) and several reported racial demographics for only one race (20.9%). When racial data was reported, Whites made up 90.2% of participants. Percentages of Black, Asian, Native American/Pacific Islander and participants considered “Other” averaged 2.9%, 11.6%, 0.5% and 1.6%, out of the total sample sizes of 3,901, 3,742, 828 and 4,027, respectively. Proportional representation of White participants decreased over time (p<0.01), while proportional representation of Asian participants increased over time (p=0.047). In ordinal logistic regression, mean year of trial enrollment significantly increased the number of racial groups reported (p<0.001).
CONCLUSIONS: Half of published randomized controlled trials in Crohn’s Disease contain no racial or ethnic demographics and the remaining often only have limited inclusion of Black, Native American/Pacific Islander and Hispanic patients. Further work should characterize representation in observational and prospective trials. Researchers should work to 1) increase reporting of racial and ethnic demographics and 2) improve recruitment and retention of marginalized populations.
PMID:37586091 | DOI:10.1093/ecco-jcc/jjad138
