Strategies to improve minority patient accrual to cancer clinical trials

Abstract

6017 Background: Clinical trials (CT) provide the basis for standards of care. However, the rate of accrual to adult cancer CT is 3% and even lower for minorities. The lack of minority patients on CT results in difficulty ascribing standards to these groups. Proposed obstacles for inadequate accrual for ethnic minority participation are speculated to be socio-economic such as an unwillingness to participate in research and a fear of experimentation. We hypothesized that obstacles to accrual on CT for minority populations are predominantly disease-related and not socio-economic. Methods: An NCI funded CT shared resource was established between a comprehensive cancer center and a public hospital serving ethnic minority and economically disadvantaged patients. Over a 3-year period, all patients were screened to determine eligibility for a cooperative or institutional CT. A dedicated team, including nurses experienced in CT, undertook extensive interaction with all patients to facilitate accrual. Results: 462 patients were screened with 134 (29%) having an identified study available. Screened patients included 238 (56%) African Americans (AA), 165 (39%) Caucasians (C), and 20 (5%) Hispanics (H). 73 subjects, 54% of eligible and 16% of all patients, were accrued to a CT. Ethnicity on CT was: AA = 61%, C = 37%, and H = 2%. These accrual rates far exceed the national norm. Reasons eligible patients did not enter a CT were: medical co-morbidities (25%), not meeting eligibility criteria (21%) and inadequate performance status (10%). Only three patients (5%) indicated they did not wish to participate in research. Conclusion: This experience documents how a dedicated research team can enter ethnic minority and low-income patients onto CT. The largest group of patients not entered was due to a study not being available. All ethnic groups were proportionately accrued to CT. Strategies to improve applicability of CT may require design of studies for patients with co-morbidities or advanced disease. No significant financial relationships to disclose.