Dr Hantel on Eligibility Criteria Associated With Racial/Ethnic Disparities in Clinical Trial Enrollment in AML

Andrew Hantel, MD, physician, Dana-Farber Cancer Institute (DFCI); instructor, medicine, Harvard Medical School, discusses eligibility criteria that may perpetuate racial and ethnic disparities in clinical trial participation in patients with acute myeloid leukemia (AML).

Hantel and colleagues conducted a study evaluating data from 1,283 real-world patients with newly diagnosed AML from the Dana-Farber Cancer Institute and 6 other hospitals across the greater Chicago area. The study focused on differences in clinical trial eligibility between Non-Hispanic White patients (n = 878) and those from minoritized populations (n = 405). Researchers aimed to determine how many of these newly diagnosed patients would have been eligible for clinical trials based on standard enrollment criteria, examining disparities by race and ethnicity.

Data presented at the 2024 ASCO Annual Meeting highlighted significant disparities in trial eligibility between racial and ethnic groups, both for intensive criteria often used in trials for younger adults and less intensive criteria applied in trials for older adults, Hantel reports. The findings revealed that patients from minoritized populations were eligible for 6.8% fewer trials compared with Non-Hispanic White patients (P < .001). Non-Hispanic White patients had a 5% to 20% higher likelihood of meeting trial eligibility criteria than patients from minoritized groups, with differences observed across Hispanic, non-Hispanic Asian, and non-Hispanic Black populations, Hantel adds.

The study also identified specific eligibility criteria that contributed most to these disparities, which varied depending on the group, he continues. Key eligibility criteria contributing to these disparities included prior malignancy (22.5% of Non-Hispanic White patients vs 17.5% of patients in minority groups; P = .04), prolonged interval (20.5% vs 12.8%; P < .001), and coronary artery disease (4.0% vs 1.0%; P = .001). Pre-existing medical conditions, such as hepatitis B, were also identified as a contributing factor, Hantel notes.

These findings underscore the need for more inclusive trial designs and eligibility criteria that consider the diverse health profiles of all patient populations to ensure equitable access to clinical trials, he concludes.