Minority accrual on a prospective study targeting a diverse U.S. breast cancer population: An analysis of Wake Forest CCOP research base protocol 97609.

Abstract

6564 Background: Clinical trial accrual rates are lower among minority patients. Wake Forest CCOP RB protocol 97609 designed to accrue 400 non-Hispanic White (NHW) and 600 minority patients to a study evaluating potential genomic single nucleotide polymorphisms as markers for breast radiosensitivty. Methods: Accrual data evaluated from 24 participating CCOPs and numerous CTSU sites. Race / ethnicity self-reported by participants (NHW, non-Hispanic Black, Hispanic/Latino, Asian /Pacific Islander, or American Indian/Alaskan Native) based on ACS reporting criteria. Results: 752 participants accrued in 14.5 mths (11/11-1/13); 402 NHW and 350 minorities. NHW accrual goal reached, 5.9 months (period 1; avg 68.4 participants /month) compared with 54 minority participants (period 1; avg 9.2 participants / month). This 7.4 ratio NHW to minority accrual is higher than expected given incidence. During 8.6 months following closure NHW enrollment (period 2), 296 minority participants accrued (avg 34.3 participants/month). An almost 4-fold increase in minority accrual raises question of accrual disparity. 19 CCOPs open in period 1 and 24 CCOPs in period 2. CTSU contributed both periods, more CTSU sites were added during period 2. Excluding all CTSU sites and five CCOPs open only in period 2, the avg minority accrual:6.8 patients / month period 1 and 10.6 patients / month period 2. The average time of accrual was 4.0 months period 1 and 8.6 months period 2 due to variable opening dates at sites. Taking time into account, the avg minority accrual rate was 0.60 patients / month / site in period 1 and 0.56 patients / site / month in period 2. CCOP minority accrual rates in period 1 vs. 2 increased 11 / 19 sites, decreased 6 / 19, and remained the same in 2 / 19, p = .33. Conclusions: Despite closure of enrollment of NHWs into this study with a specific goal to accrue a large minority population, there was no increase in the rate of minority accrual. The initial appearance of an accrual bias can be attributed to the addition of sites and variable lengths of accrual time at sites. It is unknown whether overall lower minority accrual rate compared to NHWs is participant-, provider-, or population-based. Clinical trial information: NCT01407770.