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Published in: Journal of Neuro-Oncology 1/2020

01-05-2020 | Glioma | Clinical Study

The influence of race and socioeconomic status on therapeutic clinical trial screening and enrollment

Authors: Ramin A. Morshed, Sheantel J. Reihl, Annette M. Molinaro, Sofia Kakaizada, Jacob S. Young, Jessica D. Schulte, Nicholas Butowski, Jennie Taylor, Nancy Ann Bush, Manish K. Aghi, Mitchel S. Berger, Susan Chang, Jennifer Clarke, Shawn L. Hervey-Jumper

Published in: Journal of Neuro-Oncology | Issue 1/2020

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Abstract

Purpose

Under-enrollment in clinical trials significantly limits valid analyses of clinical interventions and generalizability of findings. Often it results in premature study termination, with estimates of 22% to 50% of clinical trials terminated due to poor accrual. Currently, there are limited reports addressing the influence of race/ethnicity and socioeconomic status on clinical trial enrollment in adult glioma patients. The goal of this study was to test the hypothesis that race and socioeconomic status negatively impact therapeutic clinical trial enrollment.

Methods

988 adult patients were identified from the UCSF Tumor Board Registry and analyzed to determine the rate of therapeutic clinical trial screening and study enrollment.

Results

At initial diagnosis, 43.6% and 17.5% of glioma patients were screened and enrolled in a therapeutic clinical trial, respectively. At recurrence, 49.8% and 26.3% of patients were screened and enrolled in a clinical trial, respectively. Thirty-three percent of the study population belonged to a NIH-designated underrepresented minority group; Asian/Pacific-Islander comprised 19.6% of the overall cohort. On univariate analysis, only in-state location, distance to the hospital, and WHO grade were associated with enrollment at initial diagnosis and recurrence. Minority status, insurance type, median household income, and percent below poverty were not associated with clinical trial enrollment.

Conclusion

Minority and socioeconomic status did not impact adult glioma clinical trial enrollment. Proximity to the tertiary care cancer center may be an important consideration for minority patients. Patient screening should be carefully considered in order to avoid bias based on minority and socioeconomic status.
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Literature
3.
go back to reference NIH (2001) Guidelines on the inclusion of women and minorities as subjects in clinical research. National Institue of Health, Bethesda NIH (2001) Guidelines on the inclusion of women and minorities as subjects in clinical research. National Institue of Health, Bethesda
4.
go back to reference Freedman LS, Simon R, Foulkes MA et al (1995) Inclusion of women and minorities in clinical trials and the NIH Revitalization Act of 1993–the perspective of NIH clinical trialists. Control Clin Trials 16(277–279):293–309 Freedman LS, Simon R, Foulkes MA et al (1995) Inclusion of women and minorities in clinical trials and the NIH Revitalization Act of 1993–the perspective of NIH clinical trialists. Control Clin Trials 16(277–279):293–309
5.
go back to reference Ostrom QT, Gittleman H, Liao P et al (2017) CBTRUS Statistical Report: Primary brain and other central nervous system tumors diagnosed in the United States in 2010–2014. Neuro Oncol 19:v1–v88CrossRef Ostrom QT, Gittleman H, Liao P et al (2017) CBTRUS Statistical Report: Primary brain and other central nervous system tumors diagnosed in the United States in 2010–2014. Neuro Oncol 19:v1–v88CrossRef
6.
go back to reference Chang SM, Barker FG 2nd, Schmidt MH et al (2002) Clinical trial participation among patients enrolled in the Glioma Outcomes Project. Cancer 94:2681–2687CrossRef Chang SM, Barker FG 2nd, Schmidt MH et al (2002) Clinical trial participation among patients enrolled in the Glioma Outcomes Project. Cancer 94:2681–2687CrossRef
Metadata
Title
The influence of race and socioeconomic status on therapeutic clinical trial screening and enrollment
Authors
Ramin A. Morshed
Sheantel J. Reihl
Annette M. Molinaro
Sofia Kakaizada
Jacob S. Young
Jessica D. Schulte
Nicholas Butowski
Jennie Taylor
Nancy Ann Bush
Manish K. Aghi
Mitchel S. Berger
Susan Chang
Jennifer Clarke
Shawn L. Hervey-Jumper
Publication date
01-05-2020
Publisher
Springer US
Published in
Journal of Neuro-Oncology / Issue 1/2020
Print ISSN: 0167-594X
Electronic ISSN: 1573-7373
DOI
https://doi.org/10.1007/s11060-020-03503-x

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