Examining Clinical Research for Patients with Acute Myeloid Leukemia

Treatment for Acute myeloid leukemia (AML) is considered especially intense and varies by individual. As people age, they have less tolerance for high dose chemotherapy or intense cancer treatments. However, age is only one factor that may affect treatment, race and ethnicity, overall health, performance status, and genetic risk factors can also affect treatment and results.

Studies show that Black patients with acute myeloid leukemia are less likely to receive intensive chemotherapy or undergo allogeneic stem cell transplants when compared to White patients. They also have higher mortality rates. This is explained through various health disparities. Studies have shown that Black and Hispanic patients are affected by social drivers of health (SDOH) such as geographic location (eg, disadvantaged census tracts), transportation, structural racism, and treating hospital. These factors contribute to disparities and inequities in access to evidence-based treatment modalities and optimal health outcomes.

New treatment types for acute myeloid leukemia are being tested every day in clinical trials. For many people, participating in a clinical trial may be the best treatment option. Because treatments are approved through clinical research, it is important that they include diverse populations such as racial and ethnic minorities, sexual and gender minorities, and those with socio-economic disparities.

Research shows that people from minority and diverse backgrounds are underrepresented in clinical research. This is especially concerning regarding treatment for acute myeloid leukemia, due to its intensity and complexity. Diversity in clinical research is important to understand how patients of all backgrounds will react to a new treatment. This is because people have different experiences with the same disease.

There are many barriers to entry for clinical trials among minorities including mistrust of clinical research, insufficient recruitment and retention efforts, lack of time and resources, and transportation. Other barriers may include caregiver/family responsibilities, language or cultural differences, health literacy, religion, and lack of understanding of clinical research. In addition, a study on clinical practice highlighted the need for providers to be aware of new treatment options. The study noted that providers not familiar with agents under clinical investigation for acute myeloid leukemia with TP53 mutations, may miss an opportunity to have their patients receive emerging treatments.

Although barriers to clinical research exist, there are recommendations on how to achieve diversity among participants, including:

• Define a wider eligibility criterion. Early in the drug development process, developers should define study criterion that includes older adults or those with co-morbidities, when appropriate.
• Raise awareness on clinical trials. Research investigators should partner with community hospitals and health systems to raise awareness among providers and patients on available clinical trials.
• Utilize technology. To increase access to clinical trials, technology should be used to support increased access, especially for those with barriers like cost or lack of transportation.
• Promote diversity. Researchers in defining a wider eligibility criterion, should provide education and awareness through patient advocacy and community organizations.

Change does not happen overnight. However, making improved efforts to improve diversity in clinical research today will impact patient health outcomes in the future.

This program is supported by AbbVie.