Early success in narrowing age, gender, and racial disparities in clinical trial accrual: Targeted screening efforts through the National Cancer Institute Community Cancer Centers Program (NCCCP).

Abstract

6110 Background: The NCCCP has engaged in special programs to enhance clinical trial accrual among underserved populations. These include cultural awareness webinars, nurse/lay navigators with translated consent forms and interpreters, expansion of trials in outreach sites, community site pairing, and utilization of a web-based tracking tool to monitor clinical trial screening and accrual barriers. Methods: Screening and accrual data of 19 NCI Cooperative Group trials encompassing 9 disease categories from the geographically diverse NCCCP sites was collected between March 2009 and December 2010. The data included patient demographics, trial eligibility, trial enrollment, and reasons for non-enrollment. We used Fisher’s exact test for determination of P values. This abstract addresses patient demographics. Results: Of the 1,589 patients screened during this period, 359 were enrolled, for an overall accrual rate of 23%. The accrual rates among the various demographic subsets are shown in the table. No disparity based on gender, ethnicity, or race between Whites and African Americans (P value for the latter comparison 0.59) was found and the disparity gap between the young and elderly appears narrowed when compared to historical data (3-fold difference; Murthy VH, et al JAMA 2004). Conclusions: NCCCP has captured clinical trial screening and accrual outcome among several underserved populations coming from diverse geographic locations. Data suggests that through barrier identification and a concerted program of network strategies involving community cancer centers, disparities in clinical trial accrual have been reduced. This project funded in whole or part with federal funds from NCI, NIH under Contract No. HHSN261200800001E. # Screened # Enrolled Accrual rate (%) P Overall 1,589 359 23 -- Female 1,078 246 23 0.80 Male 511 113 22 Age > 65 689 143 21 0.09 < 65 883 216 25 Hispanic 93 20 22 0.80 Non-Hispanic 1,465 339 23 White 1,309 306 23 0.59 African American 205 44 22