Inequities in Alliance Acute Leukemia Clinical Trial and Biobank Participation: Defining Targets for Intervention

Abstract

PURPOSE Representativeness in acute leukemia clinical research is essential for achieving health equity. The National Cancer Institute's mandate for Comprehensive Cancer Centers (CCCs) to define and assume responsibility for cancer control and treatment across a geographic catchment area provides an enforceable mechanism to target and potentially remediate participatory inequities. METHODS We examined enrollee characteristics across 15 Cancer and Leukemia Group B/Alliance cooperative group adult acute leukemia clinical trials (N = 3,734) from 1998 to 2013, including participation in optional companion biobanks. We determined enrollment odds by race-ethnicity for all participants adjusted for national incidence, and for those enrolled at CCCs adjusted for catchment area incidence. We modeled biobank participation by sociodemographics using logistic regression. RESULTS Non-Hispanic (NH)-White patients were more likely to be enrolled than NH-Black, NH-Asian, or Hispanic patients (odds ratio [OR] 0.75, 0.48, and 0.44, respectively; all P < .001), but less likely than NH-Native American patients (OR 1.91; P < .001), adjusted for national incidence. Enrollment odds were lower for NH-Black, NH-Asian, and Hispanic patients at CCCs adjusted for catchment area incidence (OR 0.57, 0.26, and 0.32, respectively; P < .001); differences were driven by overenrollment of NH-White patients from outside self-defined catchment areas (18.1% v 12.3%; χ2 P = .01) and by CCCs with less absolute enrollee diversity (rank sum P = .03). Among all enrollees, NH-White race-ethnicity and lower neighborhood deprivation correlated with biobank participation (OR 1.81 and 1.45, respectively; P = .01 and .03). For CCC enrollees, the correlation of race-ethnicity with biobank participation was attenuated by a measure accounting for their site's degree of enrollment disparity but not neighborhood deprivation. CONCLUSION Acute leukemia clinical research disparities are substantial and driven by structural trial enrollment barriers at CCCs. Real-time CCC access and enrollment monitoring is needed to better align research participation with local populations.

Perspectives on Disparities and Equity in Cancer Outcomes: A Call to Action

“…Enrollment odds were lower for non-Hispanic Black, non-Hispanic Asian, and Hispanic patients at CCCs after adjustment for catchment area incidence; these differences were driven by overenrollment of non-Hispanic White patients from outside self-defined catchment areas. 22 Given the practice-changing impact of immune-checkpoint inhibitors (ICI) in the past decade, Riaz et al 23 examined 107 eligible phase II and phase III ICI randomized clinical trials with 48,095 patients and assess representation of subgroups. The results demonstrated trial participation rates of 1.9% and 5.9% for Blacks and Hispanics, and enrollment incidence ratios of 0.17 and 0.67, respectively.…”

“…Enrollment odds were lower for non-Hispanic Black, non-Hispanic Asian, and Hispanic patients at CCCs after adjustment for catchment area incidence; these differences were driven by overenrollment of non-Hispanic White patients from outside self-defined catchment areas. 22…”

A Process Framework for Ethically Deploying Artificial Intelligence in Oncology

“…5,24 This is especially important for a field where there are two inter-related genomes, the germline and somatic, and non-Hispanic Whites are over-represented in oncology biobanks. 25 These worries are compounded for AI tools used outside clinical interactions, where patients (and sometimes oncologists) may be less likely to recognize care biases or autonomy infringements. Examples include radiology, pathology, and clinical pathway decision-support tools, where few patients are aware of their existence or impact.…”

Disparities in acute myeloid leukemia treatments and outcomes

“…For example, an underrepresentation of Black patients in pivotal clinical trials has led to a lack of knowledge about possible ancestry-associated drug responses, lack of associated biobanking that could provide response information in correlative studies and subsequent lack of therapeutic advances at the same level as patient populations who participated in these pivotal studies. Disparities in enrollment by race ethnicity for AML patients were recently reported by Hantel et al [34 ▪▪ ] who analyzed enrollment demographics for 15 frontline AML trials of the Cancer and Leukemia Group B/Alliance for Clinical Trials in Oncology ( n = 3734; 1998–2014), where the authors assessed enrollment odds for each race-ethnicity category for all participants after adjusting for national incidence and catchment area for patients treated in Comprehensive Cancer Centers (CCCs). Here, non-Hispanic White patients were more likely to be enrolled in clinical trials [34 ▪▪ ].…”

“…Disparities in enrollment by race ethnicity for AML patients were recently reported by Hantel et al [34 ▪▪ ] who analyzed enrollment demographics for 15 frontline AML trials of the Cancer and Leukemia Group B/Alliance for Clinical Trials in Oncology ( n = 3734; 1998–2014), where the authors assessed enrollment odds for each race-ethnicity category for all participants after adjusting for national incidence and catchment area for patients treated in Comprehensive Cancer Centers (CCCs). Here, non-Hispanic White patients were more likely to be enrolled in clinical trials [34 ▪▪ ]. Moreover, CCC disparities were driven by over-enrollment of non-Hispanic White patients from outside of their catchment areas [34 ▪▪ ].…”