Adequate Catchment Area Representation in Cancer Clinical Trials at NCI Designated Cancer Centers: The University of California Irvine Experience

TL;DR

This paper shows how aligning clinical trials with the demographics and cancer types of a region can improve enrollment and research relevance.

Contribution

The study demonstrates a scalable model for clinical trial design based on catchment area demographics and cancer burden.

Findings

Clinical trial enrollment at UC Irvine reflects and exceeds regional demographics for Asian and Hispanic populations.

Higher enrollment was observed for specific cancers like lung/liver in Asians, breast in Hispanics, and prostate in Black patients.

Strategic trial alignment with catchment area needs enhances accrual and research generalizability.

Abstract

Ensuring that clinical trial enrollment reflects the demographics and disease burden of a cancer center's catchment area is essential for improving trial accrual and the generalizability of research findings. We hypothesized that aligning the clinical trial portfolio with the needs of the catchment area can enhance enrollment and access to novel therapeutics.

A retrospective cohort study was conducted at the University of California Irvine Chao Family Comprehensive Cancer Center (CFCCC), an National Cancer Institute‐designated cancer center serving Orange County (OC), California—the 6th largest populous county in the United States. Clinical trial enrollment data from 2015 to 2023 were analyzed using the CFCCC clinical research database. Patient demographics, tumor types, and trial enrollment patterns were compared with population‐level data from NIH SEER for both OC and the United States.

Between 2015 and 2023, 2317 participants were enrolled in clinical trials. Demographics were: White (66.4%), Asian (20.1%), Black (2.4%), American Indian/Alaska Native (0.7%), mixed/unknown (9.3%). Ethnicity: Non‐Hispanic (77.8%) vs. Hispanic (20.5%). Sex: Female (47.6%) vs. Male (52.3%). Age: < 70 years (73.3%) vs. ≥ 70 years (26.7%). Residence in low‐income/Health Professional Shortage Areas (HPSA): 44.8%. Trial phases included Phase I/II (35.6%), Phase II (25.4%), Phase II/III (2.8%), Phase III (26.6%), and Phase IV (0.3%). Study sponsors included Industry (61.1%), Institutional (23.6%), National (14.8%), and Externally Peer Reviewed (0.3%). Enrollment patterns reflected and, in some areas, exceeded the regional representation, particularly for Asian and Hispanic populations. Cancer‐type‐specific analysis showed higher enrollment for lung and liver cancers among Asians, breast cancer among Hispanics, and prostate cancer among Black patients.

These findings suggest that the strategic alignment of the clinical trial portfolio with the cancer burden and demographics of the catchment area can enhance accrual. This catchment‐based approach offers a scalable model for improving clinical trial participation and ensuring the relevance of research to the communities served.

Figures