E163: Clinical Trial Recruitment Disparities at a Regional Medical Center

Disparities in clinical trial recruitment were first published in a 2004 study, noting racial and ethnic minorities, as well as women and elderly patients had reduced participation in clinical trials.  The current study aims to evaluate clinical trial recruitment disparities at a local-regional institution 18 years later, with the null hypothesis representing no disparity.

Methods: Population data from the US Census Bureau in conjunction with incidence rates from the Surveillance, Epidemiology, and End Results Program (SEER) reports were compared to institutional clinical trial demographics with univariate analysis. This was a retrospective chart review of data from 2019-2022.

Results: A total of 331 patients were recruited to clinical trials during this time period. Our analysis was limited to the top 3 cancer primaries, 150 (45.3%) breast, 94 (28.4%) lung and bronchus (lung), and 21 (6.3%) colon and rectum (CR). The total population of the tri-county region served, is 472,848 with 50.8% being female (F), and ethnic/racial groups as follows: 75.1% non-Hispanic white (NHW), 7.2% Hispanics of any race (H), and 17.7% non-Hispanic non-white (NH-NW). The SEER incidence rates were obtained by race and cancer primary, reported as incidence per 100,000, and used to calculate expected incidents of cancer within the tri-county region. For female breast, there were 285 total expected with 236 (82.7%) NHW, 33 (11.5%) NH-NW and 16H (5.8%); Lung and Bronchus 205 expected, with 169 (82.4%) NHW, 29 (14.3%) NH-NW and 7H (3.3%); CR 156 expected with 107 (69.0%) NHW, 39 (25.2%) NH-NW, and 9H (5.8%). In comparison to the recruited data, female breast was statistically significant for disparities with 138 (92%) NH white, 8 (5.3%) NH-NW and 2H (1.3%), p-value 0.009. No statistical significance was found in either Lung or CR primaries. Recruited lung included 84 (89.3%) NH white, 6 (6.4%) NH-NW, and 1H (1.1%), p=0.082. Recruited CR included 16 NH white (76.2%), 4 (19.2%) NH-NW and no H (0%), p=0.599.

Conclusions:

Despite the recognition of recruitment disparities almost 20 years ago, our study found that such disparities still exist at the local-regional level for primary breast cancer. Although no statistical difference was identified in the lung or colorectal primaries, these were small sample sizes and are likely to have a type 2 error.  While key causes of disparities are not easily identified, additional work is still needed to mitigate disparities in clinical trial recruitment to ensure the wide applicability of emerging cancer treatments.