Equity in Clinical Trials, AML Transplant Remains Challenging

Clinical trials and transplantation remain critical components of care for patients with acute myeloid leukemia (AML), but significant barriers continue to limit equitable access, according to Karilyn Larkin, MD, a hematologic oncologist formerly of The James/The Ohio State Comprehensive Cancer Center and now director of clinical and translational research for myeloid malignancies at Wilmot Cancer Institute.

She said clinical trials are not always designed to fairly enroll people from diverse backgrounds. Although some trials may have more diversity because of the populations they target, she noted that logistics alone can make participation difficult. She also pointed to eligibility criteria, including measurements involving creatinine clearance and cardiac function, that may disadvantage some populations.

“These are long-held, sort of traditional criteria,” designed to protect patients from excessive toxicity, Larkin said. However, she noted that such criteria may not recognize how requirements can affect different populations.

Larkin also emphasized that assumptions about patients’ willingness to participate can become another barrier. When trial benefits are clearly explained, she said, patients who may need additional time, translated consent materials, or other support can still enroll successfully. For patients undergoing transplantation, the practical and financial challenges can be significant. Patients may need to relocate, take time away from work, and identify a caregiver for several months. Larking said the caregiver requirement has been a “showstopper” for several patients who could not find someone to take that time away from work.

At Ohio State, financial counselors, case managers, social workers, and medication assistance staff help patients navigate these challenges. The team can assist with grants, disability paperwork, and housing support. Still, Larkin noted that these resources are not available equally at every institution.

She believes policy changes could have the greatest impact on transplant equity. She said coverage that includes caregiver support and housing could help ensure that financial circumstances do not determine who can undergo a transplant. While enthusiastic about research, Larkin said the ultimate goal is translating those discoveries into meaningful, equitable access for every patient diagnosed with AML.