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

Abstract

Background Clinical trials provide access to innovative, quality cancer treatment. Simultaneously, broad access helps ensure trial inclusion of heterogeneous patient populations, which improves generalizability of findings and development of interventions that are effective for diverse populations. We provide updated data describing enrollment into cancer treatment trials in North Carolina. Methods For 1996 to 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, gender, and year for each county, Area Health Education Center (AHEC) region, and the state overall. Enrollment rates for common cancers are presented. Results From 1996 to 2009, North Carolina NCI treatment trial enrollment rate was 2.4% and 2.2% for whites and minorities, respectively. From 2007 to 2009, rates were 3.8% for white females, 3.5% for minority females, 1.3% for white men, and 1.0% for minority men, with greater enrollment among more urban populations (2.4%) than the most rural populations (1.5%). Limitations This study is limited to NCI-sponsored treatment trials in North Carolina. Policies governing collection of original data necessitate a delay in data availability. Conclusions Effort is needed to ensure trial access and enrollment among all North Carolina populations. Specifically, we identified racial and gender disparities, particularly for certain cancers (e.g., breast). Programs in North Carolina and across the nation can use the methods we employ to assess their success in broadening clinical trials enrollment for diverse populations.

Making the Case for Investment in Rural Cancer Control: An Analysis of Rural Cancer Incidence, Mortality, and Funding Trends

“…Another marked disparity in treatment between rural and urban cancer patients concerns recruitment into clinical trials. A study evaluating treatment trials in North Carolina found that the rate of enrollment was higher among urban populations than among the most rural populations (2.4% vs. 1.5%) (12). The authors suggested that despite initiatives like the Community Clinical Oncology Program (CCOP) and the National Community Cancer Centers Program (NCCCP) to enhance access to cancer trials and increase enrollment of diverse patients, rural residents still face access barriers to trial participation (12).…”

Racial and Ethnic Disparities in Parental Refusal of Consent in a Large, Multisite Pediatric Critical Care Clinical Trial

“…A landmark systematic review of studies related to research consent revealed that Blacks were generally as willing as any others to take part in RCTs, that remarkably few studies reported their consent rates by race and ethnicity and that the heterogeneity in how consent rates were reported prevented comparisons across studies. 3 On the other hand, there are studies that document racial and ethnic disparities in health research participation [4][5][6][7] and a recent systematic review of barriers and facilitators to minority participation in research identified mistrust, stigma, and competing demands as common barriers. 8 Unfortunately, there is a paucity of pediatric data on research consent and enrollment and even fewer studies examining this issue in critically ill children.…”

How current reporting practices may mask differences: A call for examining cancer-specific demographic enrollment patterns in cancer treatment clinical trials

“…Disparities among cancer treatment clinical trial participants are well recognized [[11], [12], [13]]. Some studies have examined disparities within specific cancer types and identified the need for accruing representative patients within a tumor type [9].…”