Clinical trial accrual among new cancer patients at a community-based cancer center - A prospective study

BACKGROUND. To the authors' knowledge, only limited data are available regarding clinical trial accrual patterns and the barriers encountered among newly diagnosed patients seen at community-based cancer centers. METHODS. In the current study, the authors prospectively collected clinical and sociodemographic data from all adult patients seen at a community-based cancer center who had new cancers diagnosed between 2003-2004. Clinical trial enrollment decisions were noted and factors that prevented accrual were identified. RESULTS. There was a total of 1012 new cancer patients. In 587 patients (58%), clinical trials appropriate for the diagnosis and stage of disease were not available. Among those patients for whom trials were available, 19.8% did not meet eligibility criteria, and only 9.9% of patients were enrolled. Although more trials were found to be available for women compared with men (51% vs. 32%; P < 0.01), the accrual rates were equal (11.2% vs. 7.6%; P = 0.24). Elderly patients comprised approximately 59.4% of those patients with available trials, but they were less likely to be enrolled (5.1% vs. 16.8%; P < 0.01). The major barriers to nonparticipation can be grouped into protocol limitations (68.1%), physician triage (16%), and patient decisions (15.9%). The overall accrual rate when all patients were included was 4% (42 of 1012 patients). CONCLUSIONS. At the study institution, participation in clinical trials is reported to be low. The unavailability of appropriate clinical trials represents the most significant barrier. Continuing efforts to encourage physicians and to educate patients remain necessary. If the current study findings are found to be applicable to other community-based cancer centers, making a larger variety of clinical trials available to the community may help to improve the accrual of patients to national cancer clinical trials.