Background: Enrollment rates into cancer clinical trials among the adult population remains at approximately 2–11% with the vast majority being white men and women from high socioeconomic status and educational backgrounds. In order to address the unequal burden of cancer among underserved populations, it is imperative to enroll representative populations into cancer clinical trials, yet little is known about reasons why minority accrual is so low. We aim to examine the eligibility and enrollment criteria for disadvantaged populations in cancer clinical trials as a first step to increase minority accrual.

Methods: Boston Medical Center, a recently designated Minority Based Community Clinical Oncology Program by the National Cancer Institute, is the largest Safety Net medical institution in New England serving Boston's most vulnerable cancer patients. Using the hospital cancer registry to identify incident cases in the calendar year 2010 (n=1300), we conducted a retrospective review of the electronic medical record (EMR) to identify rates of screening for available cancer clinical trials. Each patient considered potentially eligible for a cancer clinical trial has documentation in their EMR from a clinical trials nurse. This screening note documents potential eligibility for enrollment, reasons for ineligibility or non-enrollment. Socio-demographic information was obtained from the cancer registry. Descriptive statistics were used to report our main outcomes: screening rate, eligibility and enrollment rate (of those screened) and reasons for not enrolling.

Results: Among 1300 newly diagnosed cancer patients served in calendar year 2010, mean age 61; 49% female; 48% White, 30% Black, 11% Hispanic, 4% Asian. One hundred clinical trials were available for accrual during the time period. Overall, we found documentation that 686 screenings for specific cancer trials were performed across 547 unique patients, resulting in a screening rate of 42% of newly diagnosed cancer patients. Among all 686 screenings, we found that patients were deemed ineligible for a specific clinical trial 92% of the time (n=630). The most commonly noted reasons for ineligibility were administrative issues (such as pending IRB approval and timing of screening) versus patient co-morbidities or disease stage. Of the patients who were deemed eligible (n=56) for clinical trials, 55% (n=31) were enrolled, of which 51% were white, 45% black and 4% Hispanic.

Conclusions: Most patients screened for a cancer clinical trial were not eligible. Earlier evaluation may address the administrative issues. Co-morbidities continue to be a major source of ineligibility for minority patients. When eligible, a racially representative sample was enrolled, suggesting the need to identify trials that are specific to our patient population in order to increase minority accrual.

Citation Information: Cancer Epidemiol Biomarkers Prev 2011;20(10 Suppl):B15.