Demographic enrollment data for acute leukemia trials is suboptimal, according to a new study.
Of 223 acute myeloid leukemia (AML) trials and 97 acute lymphoblastic leukemia (ALL) trials from 2002-2017, about one-third (30.5%) and one-half (52.6%) reported enrollment by both race and ethnicity, the study showed. For both trials, non-Hispanic White patients were enrolled at significantly higher rates.
According to the study, analyses of cancer clinical trials in the early 2000s demonstrated significant disparities in enrollment by race and ethnicity.
“In response, federal and medical society policies were introduced in the late 2000s aiming to reduce such disparities by promoting data transparency through public demographic reporting,” the researchers wrote. “Little is known about disparities in enrollment and the effects of these policies on enrollment diversity for patients with acute myeloid (AML) or lymphoblastic leukemia (ALL).”
The researchers looked at demographic information for U.S. AML and ALL trials over a 15-year period to examine changes in reporting and diversity after reporting requirements were instituted.
During the study period, reporting of race increased from 44.2% of trials to 60.2%, but reporting of both race and ethnicity did not (34.8% to 38.6%).
Among those trials that included race and ethnicity, non-Hispanic Black, non-Hispanic Native American, non-Hispanic Asian, and Hispanic patients had significantly lower enrollment compared to non-Hispanic white patients (all P<0.01).
Reporting proportion by number of patients enrolled increased significantly after reporting requirements were initiated for race and race/ethnicity (all P<0.001).
Despite this, enrollment of non-Hispanic Black and Hispanic patients was significantly lower in the period after the reporting requirements for both AML and ALL.
“Further innovations are sorely needed to connect patients to appropriate clinical trials and to overcome structural and clinician-based recruitment barriers; examples include creating multilevel enrollment reporting feedback interventions, designing expansion cohorts specifically for underrepresented groups, and developing ethical reimbursement strategies for participation,” the researchers wrote.