Are socio-economic status indicators barriers for enrollment in phase 1 clinical trials?

TY - JOUR

T1 - Are socio-economic status indicators barriers for enrollment in phase 1 clinical trials?

AU - Mody, Reema

AU - DeCecco, Erica

AU - Florez, Narjust

AU - Patel, Vanisha

AU - Zhang, Lili

AU - Goy, Andre

AU - Proverbs-Singh, Tracy Ann

AU - Pecora, Andrew L.

AU - Lieber, Nicole

AU - Morawaski, Alison

AU - Mckiernan, Evan Patrick

AU - Hoffman, Nicholas

AU - Sarmasti, Lisa

AU - Schillen, Danielle

AU - Montes, Nicole

AU - Postma, Michael

AU - Gutierrez, Martin

AU - Gonzalez Velez, Miguel

N1 - Publisher Copyright: © 2026 by American Society of Clinical Oncology

PY - 2026/6

Y1 - 2026/6

N2 - 1652Background: Socio-economic Status (SES) indicators create barriers to access Phase 1 clinical trial (Ph1) enrollment, particularly for underrepresented minorities (URM). However, it remains unclear whether they directly affect enrollment after screening, or represent upstream barriers. We evaluated whether SES indicators impacted the enrollment rate in Ph1. Methods: All patients were screened for Ph1 at Hackensack University Medical Center (2014-2025). Patient ZIP codes were linked to the U.S. Census data (ACS 2018-2022) to derive neighborhood-level SES indicators: median household income (MHI), educational attainment (Bachelor), poverty rate (PR), unemployment rate (UR), and median home value (MHV). SES indicators were compared to national and state census benchmarks. The primary outcome was enrollment rate by SES indicators. We performed univariate analyses (Mann-Whitney U tests, chi-square), stratified analyses by race/ethnicity and gender, temporal trend analysis, and multivariable logistic regression. Results: A total of 1, 316 patients were screened for 140 Ph1. Demographics were non-Hispanic White (NHW) 66.2%, Hispanic 19.0%, African American/Black (AA) 7.8%, Asian 6.5%. No SES variable predicted enrollment: median income (enrolled $62, 646 vs not-enrolled $61, 820, p=0.450), education (38.3% vs 37.9%, p=0.598), poverty (12.9% vs 12.3%, p=0.416), unemployment (6.1% vs 6.0%, p=0.422), home value ($277, 461 vs $275, 697, p=0.605). SES quartile analysis showed no enrollment gradient (Q1=61.7%, Q2=58.1%, Q3=60.5%, Q4=63.8%; p=0.491). Findings were consistent across all racial/ethnic groups (all p>0.05), see Table 1, gender (all p>0.05), age groups <65 and ≥65 years (all p>0.05), and time periods 2014-2019 vs 2020-2025. When compared to their respective racial/ethnic groups U.S. Census averages, it demonstrated atypical SES profiles: Hispanic patients had higher education (36.6% vs 20.6%), AA showed higher SES across all indicators, and Asians showed lower SES, suggesting regional selection bias in who reaches Ph1 screening. Conclusions: When patients reach Ph1 screening, SES indicators do not predict enrollment, demonstrating that equitable enrollment practices can be achieved at screening. Although there were no visible SES-related barriers at the enrollment point, disparities exist among groups likely suggesting referral patterns prior to screening. Future research should examine how to improve access to Ph1 in URM and upstream inequities.

AB - 1652Background: Socio-economic Status (SES) indicators create barriers to access Phase 1 clinical trial (Ph1) enrollment, particularly for underrepresented minorities (URM). However, it remains unclear whether they directly affect enrollment after screening, or represent upstream barriers. We evaluated whether SES indicators impacted the enrollment rate in Ph1. Methods: All patients were screened for Ph1 at Hackensack University Medical Center (2014-2025). Patient ZIP codes were linked to the U.S. Census data (ACS 2018-2022) to derive neighborhood-level SES indicators: median household income (MHI), educational attainment (Bachelor), poverty rate (PR), unemployment rate (UR), and median home value (MHV). SES indicators were compared to national and state census benchmarks. The primary outcome was enrollment rate by SES indicators. We performed univariate analyses (Mann-Whitney U tests, chi-square), stratified analyses by race/ethnicity and gender, temporal trend analysis, and multivariable logistic regression. Results: A total of 1, 316 patients were screened for 140 Ph1. Demographics were non-Hispanic White (NHW) 66.2%, Hispanic 19.0%, African American/Black (AA) 7.8%, Asian 6.5%. No SES variable predicted enrollment: median income (enrolled $62, 646 vs not-enrolled $61, 820, p=0.450), education (38.3% vs 37.9%, p=0.598), poverty (12.9% vs 12.3%, p=0.416), unemployment (6.1% vs 6.0%, p=0.422), home value ($277, 461 vs $275, 697, p=0.605). SES quartile analysis showed no enrollment gradient (Q1=61.7%, Q2=58.1%, Q3=60.5%, Q4=63.8%; p=0.491). Findings were consistent across all racial/ethnic groups (all p>0.05), see Table 1, gender (all p>0.05), age groups <65 and ≥65 years (all p>0.05), and time periods 2014-2019 vs 2020-2025. When compared to their respective racial/ethnic groups U.S. Census averages, it demonstrated atypical SES profiles: Hispanic patients had higher education (36.6% vs 20.6%), AA showed higher SES across all indicators, and Asians showed lower SES, suggesting regional selection bias in who reaches Ph1 screening. Conclusions: When patients reach Ph1 screening, SES indicators do not predict enrollment, demonstrating that equitable enrollment practices can be achieved at screening. Although there were no visible SES-related barriers at the enrollment point, disparities exist among groups likely suggesting referral patterns prior to screening. Future research should examine how to improve access to Ph1 in URM and upstream inequities.

UR - https://www.scopus.com/pages/publications/105041960292

U2 - 10.1200/JCO.2026.44.16_suppl.1652

DO - 10.1200/JCO.2026.44.16_suppl.1652

M3 - Article

SN - 0732-183X

VL - 44

SP - 1652

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

ER -