Impact of research nurse clinical trial pre-screening on enrollment of underrepresented populations in genitourinary oncology (GU Onc) clinical trials at a large academic center.

141 Background: Proportional representation in clinical trials is necessary for generalizable and equitable cancer care. Analyzing accrual patterns at large academic centers can inform interventions. Clinical trial pre-screening by research nurses (CTPS) may improve accrual of underrepresented groups. We conducted a retrospective study to identify disparities in trial enrollment and assess the impact of CTPS for GU onc trials at our center. Methods: GU onc trial participants from May 2016-May 2024 were identified using the Fred Hutch Clinical Trials Management System. Race/ethnicity data was analyzed and compared to demographics of all GU onc patients (pts) seen in our clinic, and to county and state demographics from the same time period (from 2020 US Census). To assess the impact of CTPS, enrollment among groups was compared 1 year pre- (May 2022-May 2023) and post- (May 2023-May 2024) implementation. Two-sample t tests were used to compare proportions of race/ethnicity groups across all levels and to compare enrollment among groups pre/post CTPS program implementation. Results: From May 2016 to May 2024, 1,380 pts enrolled in GU onc trials. There was a significant difference in trial enrollment by race/ethnicity (p < 0.001). Proportions of White and Black/AA trial participants were concordant with our GU onc clinic population. Hispanic and Asian pts were underrepresented in trials when compared across all levels. Compared to 1 year pre-CTPS, in the 1-year post-CTPS implementation, enrollment among Black/AA pts (3% vs 5%, p = 0.22), and Asian pts (3% vs 4%, p = 0.47) improved, but did not reach statistical significance. Conclusions: Enrollment in GU onc trials among pts of Hispanic and Asian ethnicity at our ccenter is below expected compared to our internal GU onc population, however CTPS had a positive impact in enrollment in Asian pts. Additional efforts to increase under-represented accrual in clinical trials within our catchment area will expand the CTPS program to GU onc patients receiving care across WA state. Enrollment demographics vs GU onc, county, and state. Race/Ethnicity* GU Trial Participants (%) GU Onc Clinic (%) King County (%) WA State (%) Pre-CTPS (%) Post-CTPS (%) Total 1380 4199 2,269,675 7,705,281 175 216 W 1111 (81) 3368 (80) 1,273,054 (56) 4,918,820 (64) 158 (81) 190 (81) Hisp 34 (3) 159 (4) 243,021 (11) 1,059,213 (14) 6 (3) 4 (2) Asian 42 (3) 186 (4) 452,475 (20) 730,596 (10) 5 (3) 9 (4) Black 58 (4) 174 (4) 151,468 (7) 307,565 (4) 6 (3) 13 (5) *All demographics not included due to low numbers. Bold=significant p value vs GU trial participants.

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Publication Details

Journal
JCO Oncology Practice
Published
2025-10-01
DOI
https://doi.org/10.1200/op.2025.21.10_suppl.141
Primary Topic
Ethics in Clinical Research
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article
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article

Impact of research nurse clinical trial pre-screening on enrollment of underrepresented populations in genitourinary oncology (GU Onc) clinical trials at a large academic center.

Andrew Caleb Hsieh, Rosa Nadal, Jessica E. Hawley, Michael Thomas Schweizer et al.
JCO Oncology Practice
Ethics in Clinical Research
article

Impact of research nurse clinical trial pre-screening on enrollment of underrepresented populations in genitourinary oncology (GU Onc) clinical trials at a large academic center.

Andrew Caleb Hsieh, Rosa Nadal, Jessica E. Hawley, Michael Thomas Schweizer, Hiba M. Khan, Elizabeth Anne Stohr, Petros D. Grivas, Rajitha Sunkara, Heather H. Cheng, Bruce Montgomery, Todd Yezefski, Jheremy Reyes, Patrick Panlasigui, Ruben Raychaudhuri, Peter Nelson, Evan Yi-Wen Yu, Natalie Celestino
article en

Abstract

141 Background: Proportional representation in clinical trials is necessary for generalizable and equitable cancer care. Analyzing accrual patterns at large academic centers can inform interventions. Clinical trial pre-screening by research nurses (CTPS) may improve accrual of underrepresented groups. We conducted a retrospective study to identify disparities in trial enrollment and assess the impact of CTPS for GU onc trials at our center. Methods: GU onc trial participants from May 2016-May 2024 were identified using the Fred Hutch Clinical Trials Management System. Race/ethnicity data was analyzed and compared to demographics of all GU onc patients (pts) seen in our clinic, and to county and state demographics from the same time period (from 2020 US Census). To assess the impact of CTPS, enrollment among groups was compared 1 year pre- (May 2022-May 2023) and post- (May 2023-May 2024) implementation. Two-sample t tests were used to compare proportions of race/ethnicity groups across all levels and to compare enrollment among groups pre/post CTPS program implementation. Results: From May 2016 to May 2024, 1,380 pts enrolled in GU onc trials. There was a significant difference in trial enrollment by race/ethnicity (p < 0.001). Proportions of White and Black/AA trial participants were concordant with our GU onc clinic population. Hispanic and Asian pts were underrepresented in trials when compared across all levels. Compared to 1 year pre-CTPS, in the 1-year post-CTPS implementation, enrollment among Black/AA pts (3% vs 5%, p = 0.22), and Asian pts (3% vs 4%, p = 0.47) improved, but did not reach statistical significance. Conclusions: Enrollment in GU onc trials among pts of Hispanic and Asian ethnicity at our ccenter is below expected compared to our internal GU onc population, however CTPS had a positive impact in enrollment in Asian pts. Additional efforts to increase under-represented accrual in clinical trials within our catchment area will expand the CTPS program to GU onc patients receiving care across WA state. Enrollment demographics vs GU onc, county, and state. Race/Ethnicity* GU Trial Participants (%) GU Onc Clinic (%) King County (%) WA State (%) Pre-CTPS (%) Post-CTPS (%) Total 1380 4199 2,269,675 7,705,281 175 216 W 1111 (81) 3368 (80) 1,273,054 (56) 4,918,820 (64) 158 (81) 190 (81) Hisp 34 (3) 159 (4) 243,021 (11) 1,059,213 (14) 6 (3) 4 (2) Asian 42 (3) 186 (4) 452,475 (20) 730,596 (10) 5 (3) 9 (4) Black 58 (4) 174 (4) 151,468 (7) 307,565 (4) 6 (3) 13 (5) *All demographics not included due to low numbers. Bold=significant p value vs GU trial participants.

JCO Oncology PracticeVol. 21(10_suppl)
University of Washington (US), Fred Hutch Cancer Center (US), Southwestern Medical Center (US), The University of Texas Health Science Center (US), Southwestern Medical Center (US), The University of Texas Southwestern Medical Center (US)
Openalex Percentile: Top 63%
Ethics in Clinical Research
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