Racial/ethnic minority patients remain underrepresented in cancer clinical trials.
Previous studies have identified restrictive trial inclusion/exclusion criteria such as pre-existing medical conditions and abnormal laboratory test results may disproportionately exclude racial/ethnic minority cancer patients from trial participation.
Additionally, social determinants of health including insurance, education, language, financial constraints, employment status, and transportation challenges, could pose barriers to clinical trial participation for minority cancer patients.
Using the Socio-Ecological Model as a framework, this study aimed to examine differences in both clinical and social factors that may be associated with cancer clinical trial participation by race and ethnicity among a large cohort of patients with various types of cancer.
Cross-sectional study on adult patients who presented at Moffitt Cancer Center (MCC) in 2011-2021 and who were entered in the MCC Cancer Registry.
Data sources:
Cancer Registry: demographics, payment method at diagnosis, primary site and stage of the tumor, triple negative status (breast cancer patients only*), and metastatic disease;
Patient self-reported data obtained through the Electronic Patient Questionnaire (EPQ): education level, employment status, challenges when seeking care for cancer, COVID-19 infection, and personal history of cancer;
Electronic health records: abnormal laboratory test results (neutrophil count, white blood cell count, aspartate aminotransferase, bilirubin, creatinine, glomerular filtration rate) and comorbidities (ICD codes);
Soarian scheduling system: preferred language;
American Community Survey: Social Deprivation Index (Robert Granham Center).
Statistical analysis:
Patient demographic characteristics and cancer type were described.
Prevalence of clinical factors and comorbidities were assessed among all patients and compared across patient groups as defined by race and ethnicity using Kruskal-Wallis test or Wilcoxon rank-sum tests as appropriate.
Distributions of social determinants of health factors were compared across patient groups using Chi-squared tests followed by post hoc analysis with adjustment for multiple comparisons.
Table 1. Patient demographic characteristics (N=113,030)
Figure 1. Distribution of cancer sites
Figure 2.
Figure 3.
Prevalence of clinical conditions varied by race and ethnicity:
Compared to white patients,
African American/Black patients had higher prevalence of metastatic disease, abnormality in creatinine, AST, neutrophil count and eGFR, COVID-19 infection, diabetes, hepatitis, HIV infection, and history of organ transplantation;
Asian patients had higher prevalence of metastatic disease and Hepatitis; breast cancer patients of other race showed higher prevalence triple negative status.
Compared to non-Hispanic patients,
Racial and ethnical minority patients were more likely to face difficulties related to family, finance, work/school, and transportation when seeking care and were likely to come from a disadvantaged area.
Restrictive trial eligibility criteria may disproportionately impact enrollment of racial/ethnic minority patients in cancer clinical trials. Trial investigators should consider these disparities when setting clinical trial exclusion criteria to optimize patient diversity.
Social determinants of health may pose as additional barriers to trial participation for minority cancer patients. Cancer centers and investigators should provide solutions to mitigate social barriers.
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