Impact of trial site selection on minority patient recruitment in prostate cancer trials.

Abstract

1558 Background: Historically, minority patients have been underrepresented in clinical cancer trials. Despite recognition of this problem, trials in the early 2000’s showed a decrease from 10.5% to 6.2% in African American trial participation when compared to trials from the early 1990’s. The drop in trial participation is also reflected in prostate cancer trials, although Black men have a 1.76 higher prostate cancer incidence rate than White men. Using prostate cancer as an example, we investigated the impact of trial site selection on potential minority patient recruitment; thus, overcoming a major system-level barrier to trial access. Methods: We created a prostate cancer cohort by filtering our real-world data sources (CancerLinQ, Electronic Medical Office Logistics) for adult male patients with ICD10 CM code C61* or ICD9 CM code 185 on 1/1/2015 or later (cohort #1). As a pre-requisite for computing site level prostate cancer patient counts, we used claims data to attribute missing site information. Finally, to identify the most promising sites for minority trial recruitment, we ranked sites by the proportion of Black patients and the overall cohort patient count. We repeated the above steps for a subset of cohort #1, which was based on the criteria for trial NCT00887198 investigating the prostate cancer drug abiraterone (cohort #2). Results: The prostate cancer cohort (#1) had 151,261 patients, of which 99,152 (65.6%) were attributed to sites. The percentage of Black patients being treated at the top ten sites ranged from 33.0% to 66.4%, with a median of 45.2% (see table). All ten sites had participated in an interventional cancer trial, and eight had participated in prostate cancer trials. Half of them were community, and half were academic sites. The abiraterone cohort (#2) had 1,267 patients, of which 1,174 (92.7%) were attributed to sites. Among the top ten sites the Black patient percentages ranged from 23.8% to 85.7%, with a median of 39.3%. Conclusions: In an analysis of 17 recent FDA drug registration trials for prostate cancer, Black trial participation ranged from only 1.4% to 6.2%, with a median of 3.0%. In contrast, Black patients being treated at the top sites in our data ranged from 33.0% to 66.4%, with a median of 45.2% (cohort #1). The percentages for the abiraterone cohort (#2) were similar, suggesting that even after applying trial criteria the Black patient percentages remain in the double-digits at top sites. Our results demonstrate that informed trial site selection could have a substantial positive impact on minority patient recruitment. [Table: see text]