Increased accrual of diverse patient populations in oncology phase I clinical trials at the University of Colorado Cancer Center
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 inst...
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Frontiers Media S.A.
2025-07-01
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| Series: | Frontiers in Oncology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fonc.2025.1546500/full |
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| author | Ahmed Alsafar Sama L. Kareem Bradley R. Corr Christopher H. Lieu Breelyn Wilky S. Lindsey Davis D. Ross Camidge Antonio Jimeno Wells A. Messersmith Andrew Nicklawsky Daniel Pacheco Evelinn A. Borrayo Jessica D. McDermott Jennifer R. Diamond |
| author_facet | Ahmed Alsafar Sama L. Kareem Bradley R. Corr Christopher H. Lieu Breelyn Wilky S. Lindsey Davis D. Ross Camidge Antonio Jimeno Wells A. Messersmith Andrew Nicklawsky Daniel Pacheco Evelinn A. Borrayo Jessica D. McDermott Jennifer R. Diamond |
| author_sort | Ahmed Alsafar |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-8742bcb04bdf4884922e71210fb1e110 |
| institution | OA Journals |
| issn | 2234-943X |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Oncology |
| spelling | doaj-art-8742bcb04bdf4884922e71210fb1e1102025-08-20T02:37:24ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2025-07-011510.3389/fonc.2025.15465001546500Increased accrual of diverse patient populations in oncology phase I clinical trials at the University of Colorado Cancer CenterAhmed Alsafar0Sama L. Kareem1Bradley R. Corr2Christopher H. Lieu3Breelyn Wilky4S. Lindsey Davis5D. Ross Camidge6Antonio Jimeno7Wells A. Messersmith8Andrew Nicklawsky9Daniel Pacheco10Evelinn A. Borrayo11Jessica D. McDermott12Jennifer R. Diamond13School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, United StatesSchool of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, United StatesDivision of Gynecologic Oncology, Department of Obstetrics & Gynecology, University of Colorado Anschutz Medical Campus, Aurora, CO, United StatesDivision of Medical Oncology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, United StatesDivision of Medical Oncology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, United StatesDivision of Medical Oncology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, United StatesDivision of Medical Oncology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, United StatesDivision of Medical Oncology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, United StatesDivision of Medical Oncology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, United StatesUniversity of Colorado Cancer Center Biostatistics Core, University of Colorado Anschutz Medical Campus, Aurora, CO, United StatesUniversity of Colorado Cancer Center Office of Community Outreach and Engagement, University of Colorado Anschutz Medical Campus, Aurora, CO, United StatesUniversity of Colorado Cancer Center Office of Community Outreach and Engagement, University of Colorado Anschutz Medical Campus, Aurora, CO, United StatesDivision of Medical Oncology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, United StatesDivision of Medical Oncology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, United StatesBackgroundDisparities 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.https://www.frontiersin.org/articles/10.3389/fonc.2025.1546500/fullclinical trialsphase Icancersocial determinants of healthhealth disparities |
| spellingShingle | Ahmed Alsafar Sama L. Kareem Bradley R. Corr Christopher H. Lieu Breelyn Wilky S. Lindsey Davis D. Ross Camidge Antonio Jimeno Wells A. Messersmith Andrew Nicklawsky Daniel Pacheco Evelinn A. Borrayo Jessica D. McDermott Jennifer R. Diamond Increased accrual of diverse patient populations in oncology phase I clinical trials at the University of Colorado Cancer Center Frontiers in Oncology clinical trials phase I cancer social determinants of health health disparities |
| title | Increased accrual of diverse patient populations in oncology phase I clinical trials at the University of Colorado Cancer Center |
| title_full | Increased accrual of diverse patient populations in oncology phase I clinical trials at the University of Colorado Cancer Center |
| title_fullStr | Increased accrual of diverse patient populations in oncology phase I clinical trials at the University of Colorado Cancer Center |
| title_full_unstemmed | Increased accrual of diverse patient populations in oncology phase I clinical trials at the University of Colorado Cancer Center |
| title_short | Increased accrual of diverse patient populations in oncology phase I clinical trials at the University of Colorado Cancer Center |
| title_sort | increased accrual of diverse patient populations in oncology phase i clinical trials at the university of colorado cancer center |
| topic | clinical trials phase I cancer social determinants of health health disparities |
| url | https://www.frontiersin.org/articles/10.3389/fonc.2025.1546500/full |
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