Increased Accrual of Diverse Patient Populations in Oncology Phase I Clinical Trials at the University of Colorado Cancer Center

Ahmed Alsafar¹Sama L Kareem¹Bradley R Corr²Christopher Lieu³Breelyn Wilky³S. Lindsey Davis³D. Ross Camidge³Antonio Jimeno³Wells A Messersmith³Andrew Nicklawsky⁴Daniel Pacheco⁵Evelinn A Borrayo⁵Jessica D Mcdermott³Jennifer R Diamond^3*

• ¹School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
• ²Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado Anschutz Medical Campus, Aurora, United States
• ³Division of Medical Oncology, Department of Medicine, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
• ⁴University of Colorado Cancer Center Biostatistics Core, University of Colorado Anschutz Medical Campus, Aurora, United States
• ⁵University of Colorado Cancer Center Office of Community Outreach and Engagement, University of Colorado Anschutz Medical Campus, Aurora, United States

Background: Disparities 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.Methods: We 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. Results: A 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.Conclusion: The 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.