Abstract
There are significant racial and ethnic disparities in the incidence and survival of patients with acute myeloid leukemia (AML). Understanding the discrepancies in enrollment in randomized controlled trials (RCTs) is important for better informing access to care and clinical trial conduct. We systematically reviewed the literature on the enrollment of racial/ethnic minorities and older adults into RCTs of AML. MEDLINE was searched from inception through June 2023 for RCTs on disease-modifying therapy for AML in adults. The proportion of trials reporting racial and ethnic subgroups, the enrollment proportions for each race, and age ≥65 years were determined, which were stratified by year, trial phase, and geographic location. A meta-analysis of enrollment incidence ratios (EIRs), the ratio of trial proportions of members of a racial and ethnic subgroup divided by the US population-based incidence, was conducted. A total of 7759 titles and abstracts and 157 full texts were screened, yielding 90 studies. Up to 23.3% of trials reported race or ethnicity, and 28.9% reported age ≥65 years. Of the trials reporting race, 4.7% of participants were Black, 9.8% Asian/Pacific Islander, 0.5% Native American/Alaska Native, 80.8% White, and 3.4% Hispanic. Hispanic patients (EIR, 0.28), and Asian patients (EIR, 0.16) were significantly underrepresented, whereas White patients (EIR, 1.23) were significantly overrepresented. When stratifying by year, we found an increase in the proportion of trials reporting on race in the last 10 years (46.2% vs 19.5%) and an increase in the last 20 years in the proportion of racial minorities enrolled.