Practice type & race influence enrollment onto clinical oncology trials: A Patterns of Care Study analysis

Abstract

6106 Background: The purpose of this study was to identify key factors influencing accrual to clinical oncology trials.Methods: Patterns of Care Study (PCS) surveys from sites studied between 1992–94 and 1996–99 (prostate cancer [1149 patients], breast cancer [1080 patients], esophageal cancer [818 patients]) were analyzed. PCS is an NCI-funded national survey of randomly selected radiation (RT) institutions in the U.S. Patients with non-metastatic disease, who received RT as definitive or adjuvant therapy, were randomly selected. To determine national estimates, the sample size was weighted by the relative contribution of each institution and patients within each institution. Accordingly, 3,047 patient records were reviewed by trained research associates; the weighted sample size was 132,890. The following factors (age, gender, race, type of insurance and practice type of treating institution [academic or not]) were studied by univariate and multivariate (MVA) analyses.Results: Only 2.7% of all patients were accrued to clinical oncology protocols, consistent with national estimates. On MVA, practice type (p=0.009) and race (p=0.012) were significant predictors of accrual. On univariate analysis, 9.4% of patients treated with RT at an academic practice were accrued vs. 1.7% at non-academic sites (p=0.011). Yet, the vast majority (87%) of all patients were seen at non-academic sites. White patients enrolled onto studies more than African Americans (2.8% vs. 0.8%, p=0.024). Younger age demonstrated a trend towards increased enrollment (3.5% for <70 yrs vs. 1.5% for ≥70 yrs, p=0.058). However, gender and type of insurance were not predictive. A trend towards increased accrual over time was observed (1.5% from '92-'94 vs. 4.2% from '96-'99, p=0.058).Conclusions: Practice type and race significantly influence accrual onto clinical oncology trials. To enhance enrollment, increased communication & education regarding protocols is essential, particularly focused on physicians in non-academic settings and minority patients. Supported by NCI grant CA 65435. No significant financial relationships to disclose.