Demographic reporting mandates fail to reduce disparities in acute leukemia trials
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Demographic reporting requirements established more than a decade ago to improve diversity in acute leukemia clinical trials did not appear to result in greater enrollment of Black and Hispanic patients, according to a study in Blood Advances.
“Enrollment inequities by race and ethnicity have been well-documented across different treatment modalities for common solid tumor cancers. Despite the unique care patterns of acute leukemia — patients are treated rapidly, in the inpatient setting, and more frequently at large referral centers — there were few data characterizing the race and ethnicity enrollment diversity in clinical trials,” Andrew Hantel, MD, oncologist at Dana-Farber Cancer Institute, told Healio. “Moreover, data were limited on the effect of initial federal and medical society policies introduced in the late 2000s that aimed to reduce such disparities by promoting data transparency through public demographic reporting.”
Hantel and colleagues examined demographic data reporting and enrollment diversity of 223 acute myeloid leukemia trials and 97 acute lymphoblastic leukemia trials conducted in the U.S. between 2002 and 2017. Researchers also assessed changes in reporting and diversity after the implementation of requirements to report demographic enrollment data.
According to study results, 30.5% of AML trials and 52.6% of ALL trials reported enrollment by race and ethnicity. Of these, the AML trials included 6,554 patients and the ALL trials included 4,149 patients.
Compared with white patients, researchers found significantly lower clinical trial enrollment among Black (AML OR = 0.68; ALL OR = 0.74), Hispanic (AML OR = 0.83; ALL OR = 0.64), Asian (AML OR = 0.75; ALL OR = 0.67) and Native American (AML OR = 0.31; ALL OR = 0.27) patients (P .01 for all).
The proportion of clinical trials that reported race increased from 44.2% to 60.2% (P = .02) after the reporting mandates, but the proportion of clinical trials that reported both race and ethnicity did not increase significantly (34.8% vs. 38.6%).
However, researchers observed significant increases after the mandates in reporting proportions by number of patients enrolled, from 51.7% to 72.7% for reporting of race and from 39.5% to 45.4% for reporting of race and ethnicity (P < .001 for both). They also reported a decrease in the relative enrollment of Black (AML OR = 0.79; ALL OR = 0.35) and Hispanic patients (AML OR = 0.77; ALL OR = 0.25).
“Overall, these data indicate substantial data absenteeism, such as a lack of data representation from underprivileged groups, especially among adult trials and those not sponsored by the NIH,” Hantel said. “For both AML and ALL clinical trials, white patients were enrolled at significantly higher rates vs. other groups. In addition, enrollment disparities were lower for trials sponsored by the NIH and for pediatric trials, though disparities were still seen for patients within these groups. There were some improvements in the public disclosure of enrollee demographics after the federal reporting requirements, which coincided with a decrease in the diversity of Black and Hispanic enrollees.”
These data further support the growing evidence showing that cancer clinical trial enrollment disparities have overlapping etiologies, including disparate trial access, research mistrust, increased trial participation costs and unnecessarily restrictive enrollment criteria that a single policy-level intervention cannot resolve, Hantel added.
“We plan to further characterize social determinants that may mediate race and ethnicity disparities, better understand what the most significant barriers to trial enrollment are for diverse groups with acute leukemia, and work with these individuals to develop interventions so that we can ensure access to and support during clinical trial participation for all persons with acute leukemia,” Hantel told Healio.
For more information:
Andrew Hantel, MD, can be reached at Dana-Farber Cancer Institute, 450 Brookline Ave., Boston, MA 02116; email: andrew_hantel@dfci.harvard.edu.
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