Enrollment and Racial Disparities in Cancer Treatment Clinical Trials in North Carolina.

Abstract

Clinical trials provide access to innovative, high-quality cancer treatment. Simultaneously, broad access helps to ensure that trials include heterogeneous patient populations, which improves the generalizability of findings and the development of interventions that are effective for diverse populations. We provide updated data describing enrollment into cancer treatment trials in North Carolina. For the period 1996-2009, person-level data regarding cancer clinical trial enrollment and cancer incidence were obtained from the North Carolina Central Cancer Registry and the National Cancer Institute (NCI). Enrollment rates were estimated as the ratio of trial enrollment to cancer incidence for race, sex, and year for each county, Area Health Education Center region, and the state overall. Enrollment rates for common cancers are presented. From 1996 to 2009, North Carolina NCI treatment trial enrollment rates were 2.4% and 2.2% for white patients and minority patients, respectively. From 2007 to 2009, rates were 3.8% for white women, 3.5% for minority women, 1.3% for white men, and 1.0% for minority men; there was greater enrollment among more urban populations (2.4%) than among the most rural populations (1.5%). This study is limited to NCI-sponsored treatment trials in North Carolina. Policies governing collection of original data necessitate a delay in data availability. Effort is needed to ensure trial access and enrollment among all North Carolina populations. Specifically, we identified racial and sex disparities, particularly for certain cancers (eg, breast cancer). Programs in North Carolina and across the nation can use the methods we employed to assess their success in broadening clinical trial enrollment to include diverse populations.