2021 / Kahn, J. M., Gray, D. M., Oliveri, J. M., Washington, C. M., DeGraffinreid, C. R., & Paskett, E. D.

Strategies to improve diversity, equity, and inclusion in clinical trials

There is a growing need for diversity, equity, and inclusion (DEI) in cancer care. One area requiring immediate attention and solutions is equal access and accrual to clinical trials. Increasing DEI in clinical trials is identified as a high-priority area by both the Institute of Medicine1 and the National Cancer Institute (NCI); however, persistent underenrollment of Black, Indigenous, and People of Color (BIPOC) and socially disadvantaged populations represents an unresolved disparity in cancer medicine. Today, overall cancer clinical trial enrollment (CTE) in the United States is 8% (6.3%-7.0% at community centers and 14.0%-15.9% at academic centers),2-4 and BIPOC patients represent only approximately 15% of that low overall participation.5,6 With diverse ethnic and racial groups composing nearly 40% of the US population,4 this staggering mismatch of racial and ethnic representation in cancer clinical trials must be addressed. Underrepresentation of minority patients in clinical trials compromises the generalizability of trial results,7-9 may lead to miscalculations of disease-free survival rates and to erroneous estimates of treatment efficacy,10 and, as a result, may further exacerbate health disparities.11 Proposed barriers to CTE in minority and low-income populations operate at multiple levels (Fig. 1). At system levels, geographic access, trial availability, and insurance barriers may disproportionately affect minority patients. System-level factors may include a lack of research or regulatory support in underresourced hospital settings; this effectively makes it impossible for these sites to open clinical trials. Patient-level factors affecting CTE include (but are not limited to) health beliefs and sociocultural factors, logistical barriers related to work and social support, and mistrust. Non–English- speaking patients may additionally be faced with language barriers that can lead to misunderstanding if communication with interpreters is not prioritized. Additionally, underenrollment of BIPOC patients in clinical trials may be the result of providers being less likely to offer trials to these populations for reasons related to their own biases or health beliefs (Fig. 1). Over the last decade, large-scale efforts to increase DEI in clinical trials have included expanded eligibility criteria, centralized translation services, and remote consent/monitoring options, with all garnering robust support from clinical trial consortia, national cancer foundations, and, most recently, the US federal government. Unfortunately, rates of minority participation remain low despite these efforts and do not reflect the higher incidence of cancer observed in these populations.12-14 In the commentary that follows, we reflect on the ongoing efforts to increase clinical trial diversity and consider whether, in addition to national and policy-level interventions, a shift in care delivery and clinical practice at the local level may also be important.


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