Demographic enrollment reporting for clinical trials in acute leukemia are “suboptimal”, according to a recent study.
In the early 2000s, analyses of cancer clinical trials showed significant disparities in enrollment according to race and ethnicity. In response, federal and medical society policies were introduced to reduce these disparities though public demographic reporting.
In this study, researchers looked at all demographic data reporting and enrollment diversity from acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML) trials in the United States from 2002 to 2017. They also compared reporting before and after reporting policies changed.
Less than one-third of 223 AML trials (30.5%) and only about one-half of 97 ALL trials (52.6%) reported enrollment by both race and ethnicity. Of those trials that did report this information, non-Hispanic Black, non-Hispanic Native American, non-Hispanic Asian, and Hispanic patients all had significantly lower enrollment compared with non-Hispanic Whites, after adjusting for race-ethnic disease incidence (P<0.01 for all). However, the proportion of trials reporting race did increase significantly after implementation of the reporting requirements (44.2% vs. 60.2%; P=0.02). Race/ethnicity reporting did not increase.
“After the initial federal efforts aimed at increasing enrollment diversity through public reporting requirements were instituted, reporting remained suboptimal but increased for some populations, and especially for adult trials and those not sponsored by the NIH,” the researchers wrote.
Significant increases in racial demographic reporting were found in AML trials (39.0% vs. 57.6%; P=0.02), but not for ALL trials (60.0% vs. 70.8%; P=0.36).
“These enrollment diversity data support the growing evidence that cancer clinical trial enrollment disparities have overlapping etiologies, including disparate trial access, research mistrust, increased trial participation costs, and unnecessarily restrictive enrollment criteria, which a single intervention cannot resolve,” the researchers concluded.