by race and ethnicity
Susan T. Vadaparampil, PhD2,5;Dana E. Rollison, PhD1
4Department of Head and Neck-Endocrine Oncology, 5Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA
Background
Racial/ethnic minority patients remain underrepresented in cancer clinical trials.
Previous studies have identified that 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.
Methods
We conducted a cross-sectional analysis of adult patients who presented at Moffitt Cancer Center (MCC) in 2011-2021 and who were entered in the MCC Cancer Registry.
Data sources and variables:
Cancer Registry: demographics, payment method at diagnosis, and primary site;
Patient self-reported data obtained through the Electronic Patient Questionnaire (EPQ): education level, employment status, challenges when seeking care for cancer, and personal history of cancer;
Electronic health records (EHR): abnormal laboratory test results (neutrophil count, white blood cell count, aspartate aminotransferase [AST], bilirubin, creatinine, and glomerular filtration rate [eGFR]) and comorbidities (based on ICD diagnosis 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.
Post hoc analyses were performed to compare each of the racial minority group with a common reference group (White) with adjustment for multiple comparisons.
Using laboratory test results from the electronic health records, the proportion of patients considered to be ineligible were reported based on commonly used thresholds for each corresponding test.
Distribution of factors related to social determinants of health were compared across patient groups using Chi-squared tests followed by post hoc analysis with adjustment for multiple comparisons.
Results
Table 1. Patient demographic characteristics (N=113,030)
Figure 1. Distribution of cancer sites
Figure 2. Prevalence of clinical factors commonly included as trial eligibility criteria by categories of race and ethnicity
Table 2. The proportion of patients ineligible to participate in a trial based on different thresholds for laboratory values
Figure 3. Social determinants of health by race and ethnicity
Conclusions
Prevalence of clinical conditions varied by race and ethnicity:
Compared to White patients,
African American/Black patients had higher prevalence of abnormality in creatinine, AST, neutrophil count and eGFR, diabetes, hepatitis, HIV infection, and history of organ transplantation;
Asian patients had higher prevalence of Hepatitis.
Compared to non-Hispanic patients,
- Hispanic patients had higher prevalence of abnormal AST result, diabetes, HIV infection, and history of organ transplantation.
Racial and ethnical minority patients were more likely to face difficulties related to family, finance, work/school, and transportation when seeking care at Moffitt 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.
Different thresholds used to detect abnormality in lab tests significantly influenced the number of patients eligible for potential trial enrollment.
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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