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AML Trial Eligibility Criteria Disparities Highlighted at ASCO 2024

• A study presented at ASCO 2024 reveals that patients from minoritized populations with acute myeloid leukemia (AML) are less likely to meet clinical trial eligibility criteria compared to Non-Hispanic White patients. • Key eligibility criteria contributing to disparities include prior malignancy, prolonged interval, coronary artery disease, and pre-existing conditions like hepatitis B, varying among different ethnic groups. • Non-Hispanic White patients had a 5% to 20% higher likelihood of meeting trial eligibility criteria, with significant differences observed across Hispanic, non-Hispanic Asian, and non-Hispanic Black populations. • The findings underscore the urgent 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.

Racial and ethnic disparities in clinical trial enrollment for acute myeloid leukemia (AML) were spotlighted at the 2024 ASCO Annual Meeting, with a study revealing significant differences in eligibility based on race and ethnicity. The research emphasizes the need for more inclusive trial designs to ensure equitable access for all patient populations.
The study, led by Andrew Hantel, MD, from Dana-Farber Cancer Institute, analyzed data from 1,283 real-world patients with newly diagnosed AML across multiple hospitals. It compared clinical trial eligibility between Non-Hispanic White patients (n = 878) and those from minoritized populations (n = 405) based on standard enrollment criteria.

Disparities in Trial Eligibility

The findings indicated that patients from minoritized populations were eligible for 6.8% fewer trials compared to Non-Hispanic White patients (P < .001). According to Hantel, 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.

Key Contributing Factors

The study identified specific eligibility criteria that significantly contributed to these disparities. These 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 contributing factors.

The Path Forward

These results highlight the critical need for revised and more inclusive trial designs and eligibility criteria. By considering the diverse health profiles of all patient populations, researchers and clinicians can work towards ensuring equitable access to clinical trials and improving outcomes for all individuals with AML.
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Reference News

[1]
Dr Hantel on Eligibility Criteria Associated With Racial/Ethnic Disparities in Clinical Trial ...
onclive.com · Aug 29, 2024

A study by Andrew Hantel, MD, and colleagues at Dana-Farber Cancer Institute and 6 other hospitals found that patients f...

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