AUTHOR=Alsafar Ahmed , Kareem Sama L. , Corr Bradley R. , Lieu Christopher H. , Wilky Breelyn , Davis S. Lindsey , Camidge D. Ross , Jimeno Antonio , Messersmith Wells A. , Nicklawsky Andrew , Pacheco Daniel , Borrayo Evelinn A. , McDermott Jessica D. , Diamond Jennifer R. 

TITLE=Increased accrual of diverse patient populations in oncology phase I clinical trials at the University of Colorado Cancer Center

JOURNAL=Frontiers in Oncology

VOLUME=Volume 15 - 2025

YEAR=2025

URL=https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1546500

DOI=10.3389/fonc.2025.1546500

ISSN=2234-943X

ABSTRACT=BackgroundDisparities in cancer outcomes persist between racial, ethnic, and socioeconomic groups. One potential cause is lack of appropriate representation in dose-finding clinical trials. We investigated the extent of disparities in phase I clinical trials and recent changes in the setting of institutional efforts to mitigate disparities, legislative interventions, FDA guidance for sponsors and the COVID-19 pandemic.MethodsWe performed a retrospective review of patients enrolled in phase I clinical trials at the University of Colorado Cancer Center in 2018–2019 and 2022-2023. We collected demographics, area deprivation index (ADI), tumor type and other clinical variables. Differences between cohorts were evaluated with t-tests, chi-Square test, or Fisher exact test. Progression-free survival (PFS) and overall survival (OS) were calculated using the Kaplan-Meier method. Hazard ratios (HR), confidence intervals (CI) and p-values were derived using the Cox-proportional hazards method.ResultsA total of 361 patients were included (209 and 152 in the 2018–2019 and 2022–2023 cohorts, respectively). The population consisted of 85.0% White, 3.3% Asian, 1.4% Black, 0.3% Native Hawaiian or Pacific Islander and no American Indian/Alaskan Native (AIAN) patients by race, and 9.1% Hispanic by ethnicity. The most common tumor type was colorectal cancer (18.3%). Compared to 2018-2019, we observed increases in non-English speakers from 1.9% (4/209) to 6.6% (10/152) (p = 0.028) and in translated informed consent forms (ICFs) from 1.4% (3/209) to 5.9% (9/152) (p = 0.033) in 2022-2023. There were no significant changes in race, ethnicity, insurance, or tumor type, although there was a moderate increase in Hispanic patients from 8.1% to 10.5%. There were no differences in clinical outcomes by race, ethnicity, or ADI scores in the overall study population. However, in the most common cancer type, colorectal cancer, higher ADI scores were associated with decreased median PFS and OS.ConclusionThe interventions resulted in an increase in accrual of non-English speaking patients, however, there was not yet a significant change in overall race and ethnicity. Our study confirms poorer outcomes for patients with higher ADI scores. Further research is warranted to understand disparities in clinical trial accrual, and intervention is needed to improve outcomes for disadvantaged patients.