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Description
Objective: Cancer clinical trial enrollment data specific to Moores Cancer Center (MCC) has not been previously evaluated with regard to racial/ethnic and sociodemographic disparities. The primary objective of the current research is to examine patterns and predictors of clinical trial enrollment with respect to certain key demographic variables such as race/ethnicity, age, gender, insurance status, and continuum of care among patients who were enrolled in cancer clinical trials offered at MCC during the years 2007-2011. Methods: A retrospective review of patient data from the general MCC patient tumor registry database was conducted, as well as a review of patient records obtained directly from the MCC Clinical Trials Office (CTO). Approximately 15,055 data on patients from MCC, UC San Diego, and 1144 data from patients tracked through the CTO database were included in the final analysis. The outcome of interest was enrollment into any therapeutic clinical trial offered at MCC during the years 2007-2011. Bivariate and multivariate logistic regression was used to determine significant associations between cancer clinical trial enrollment and sociodemographic factors historically correlated with clinical trial enrollment and healthcare access. Results: Of the 15,055 MCC patient records reviewed, 7.6% (n = 1144) of patients were enrolled into a clinical trial during the years of 2007-2011. The race/ethnicity of those patients enrolled into therapeutic clinical trials at MCC was significantly different than the race/ethnicity of those MCC patients reported to the tumor registry database (p = 0.005). Factors independently associated with clinical trial enrollment were: reporting the ethnicity of "Hispanic" (AOR: 0.65, 95% CI: 0.33, 0.80), reporting the race of African American (AOR: 0.72, 95% CI: 0.52, 0.99), reporting the race of Asian (AOR: 0.75 95% CI: 0.56, 0.99), being over the age of 65 years (AOR: 0.57 95% CI: 0.48, 0.65), reporting a marital status of "single" rather than married (AOR: 0.65 95% CI: 0.55, 0.76), being diagnosed at MCC but treated at another medical facility (AOR: 0.07 95% CI: 0.01, 0.50), being diagnosed and treated at an institution other than MCC (AOR: 0.34, 95% CI: 0.24, 0.48), reporting a smoking status of "current" as opposed to never (AOR: 0.72, 95% CI: 0.58, 0.91), and having a primary cancer site diagnosis of prostate, bladder, or kidney (AOR: 0.21, 95% CI: 0.16, 0.28), blood/lymph/bone (AOR: 0.75, 95% CI: 0.61, 0.91), or Gastrointestinal (AOR: 0.63, 95% CI: 0.52, 0.77), when compared to the referent group of breast cancer. Conclusions: These findings reveal that although a substantial number of patients at MCC may have the opportunity to enroll in a therapeutic clinical trial, significant enrollment disparities exist across the predictor variables of race/ethnicity, age, and primary cancer site diagnosis. Knowledge of these disparities can be used to focus efforts and refine best practices for the recruitment and inclusion of all patients into clinical trials. In addition, it is necessary to prospectively gather data, both qualitative and quantitative, that will examine the causes for under or non-enrollment of certain populations, in order to facilitate effective programs that will increase access for all patients regardless of race, age, or disease status.
