Race and Age Disparities in Randomized Trials of Acute Myeloid Leukemia: A Systematic Review and Meta-Analysis

• Our systematic review and meta-analysis revealed poor reporting of racial data and underrepresentation of racial minorities in RCTs

• There was an increase in the last decade in the proportion of trials reporting race and the proportions of racial minorities enrolled.

There are significant racial and ethnic disparities in the incidence and survival of patients with acute myeloid leukemia (AML). Understanding discrepancies in enrollment in randomized controlled trials (RCTs) is important to better inform access to care and clinical trial conduct. We systematically reviewed the literature on the enrollment of racial/ethnic minority, and older adults into RCTs of AML. MEDLINE was searched from inception through to June 2023 for RCTs of disease modifying therapy for AML in adults. The proportion of trials reporting racial and ethnic subgroups, the enrollment proportions of each race, and age ≥65 were determined, which were stratified by year, trial phase, and geographical location. A meta-analysis of enrollment incidence ratios (EIRs), the ratio of trial proportions of members of a racial and ethnic subgroup divided by United States (US) population-based incidence, was conducted. 7,759 titles and abstracts and 157 full texts were screened, yielding 90 studies. 23.3% of trials reported race or ethnicity and 28.9% reported age ≥65 years. Of 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, while 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 of the proportion of racial minorities enrolled.