Abstract B085: Shifting sociodemographic characteristics of a phase 1 oncology clinical trial population at an NCI-designated Comprehensive Cancer Center in the Southeast in comparison to its catchment area
Authors: Lalonde Chloe S. , Switchenko Jeffrey M. , Behera Madhusmita , Bilen Mehmet A. , Owonikoko Taofeek K. , Lewis Colleen M. , Hitron Elise , Collins Hannah , Goodale Tracy B. , Judson Emma C. , Cavalcante Ludimila , Harvey R. Donald , Carlisle Jennifer W. 
Published: January 2023

Abstract
Background: Racial and ethnic minority populations are consistently under-represented in oncology clinical trials despite comprising a disproportionate share of cancer burden. Due in part to difficulties associated with participation, phase 1 (P1) oncology trials pose a unique challenge and opportunity for minority inclusion. Here we examine the sociodemographics of P1 cancer clinical trial patients at an NCI-designated Comprehensive Cancer Center compared to all patients treated at the center, patients with new cancer diagnoses in metropolitan Atlanta (ATL), and the state of Georgia (GA). Methods: Patients enrolled on P1 trials at the Winship Cancer Institute (WCI) from 2015- 2020, identified from a data warehouse, were compared to new patient registrations at WCI from 2015-2020. Patients with cancer in metro ATL and GA were identified from the SEER Nov 2018 Submission. Covariates for the P1 and WCI institutional cohorts included sex, race, insurance, zip code. Covariates for SEER patients included sex and race. Median income by zip code per Census 2020 data was divided in quartiles per Census 2020 GA income distribution. Summary statistics are reported for categorical variables using frequencies and percentages. Comparisons between groups were conducted using one-sample proportion tests. Trends were assessed using the Cochran-Armitage test. Results: From 2015-2020, 2325 patients (43.4% F, 56.6% M) signed consent for P1 trials. Grouped race distribution was 70.3% White, 26.2% Black, 3.5% Other. Insurance distribution was 42.9% private, 48% government, 9.1% uninsured/other. Of new patient registrations at WCI from 2015-2020 (N=107497) (50.0% F, 50.0% M), grouped race distribution was 63.3% W, 32.0% B, 4.7% O. ATL 2015 SEER patients (N=31101) (50.3%F, 49.7%M) showed grouped race distribution 58.4% W, 37.2% B, 4.3% O. GA 2015 SEER patients (N=99487) (48.6%F, 51.4%M) showed grouped race distribution 71.2% W, 26.7% B, 2.1% O. Race and sex distribution of P1 patients was significantly different than WCI and ATL SEER patients (p&lt; 0.001). Comparing the P1 and WCI groups from 2015-2020, percent female did not change over time in either group (p=0.54 P1; p=0.063 WCI). Percentage of white patients did decrease over time in both groups (p=0.009 P1; p&lt;0.001 WCI). Percent of P1 patients with private insurance was higher than the WCI group (p&lt;0.001). Percent of P1 and WCI patients living in zip codes with lower median household income (Q1 & Q2) were 19.6% and 20.4%, respectively (p=0.41). Conclusions: Although P1 patients at WCI were more likely to be white, male, and privately insured, from 2015-2020, the percentage of white patients in P1 oncology clinical trials and amongst all new cancer patients treated at WCI decreased significantly. This data serves to initially characterize the existing racial disparities in oncology clinical trials in metro ATL and GA, and will lead to further understanding to ultimately improve representation of patients from racial and ethnic minority backgrounds in P1 clinical trials in our catchment area.
Citation Format: Chloe S. Lalonde, Jeffrey M. Switchenko, Madhusmita Behera, Mehmet A. Bilen, Taofeek K. Owonikoko, Colleen M. Lewis, Elise Hitron, Hannah Collins, Tracy B. Goodale, Emma C. Judson, Ludimila Cavalcante, R. Donald Harvey, Jennifer W. Carlisle. Shifting sociodemographic characteristics of a phase 1 oncology clinical trial population at an NCI-designated Comprehensive Cancer Center in the Southeast in comparison to its catchment area [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr B085.