A population study of clinical trial accrual for women and minorities in neuro-oncology following the NIH Revitalization Act

Sheantel J. Reihl; Nirav Patil; Ramin A. Morshed; Mulki Mehari; Alexander Aabedi; Ugonma N. Chukwueke; Alyx B. Porter; Valy Fontil; Gino Cioffi; Kristin Waite; Carol Kruchko; Quinn Ostrom; Jill Barnholtz-Sloan; Shawn L. Hervey-Jumper

doi:10.1093/neuonc/noac011

A population study of clinical trial accrual for women and minorities in neuro-oncology following the NIH Revitalization Act

Sheantel J. Reihl, Nirav Patil, Ramin A. Morshed, Mulki Mehari, Alexander Aabedi, Ugonma N. Chukwueke, Alyx B. Porter, Valy Fontil, Gino Cioffi, Kristin Waite, Carol Kruchko, Quinn Ostrom, Jill Barnholtz-Sloan, Shawn L. Hervey-Jumper

Neurology

Research output: Contribution to journal › Article › peer-review

Abstract

Background: The NIH Revitalization Act, implemented 29 years ago, set to improve the representation of women and minorities in clinical trials. In this study, we investigate progress made in all phase therapeutic clinical trials for neuroepithelial CNS tumors stratified by demographic-specific age-adjusted disease incidence and mortality. Additionally, we identify workforce characteristics associated with clinical trials meeting established accrual benchmarks. Methods: Registry study of published clinical trials for World Health Organization defined neuroepithelial CNS tumors between January 2000 and December 2019. Study participants were obtained from PubMed and ClinicalTrials.gov. Population-based data originated from the CBTRUS for incidence analyses. SEER-18 Incidence-Based Mortality data was used for mortality analysis. Descriptive statistics, Fisher exact, and χ2 tests were used for data analysis. Results: Among 662 published clinical trials representing 49 907 participants, 62.5% of participants were men and 37.5% women (P <. 0001) representing a mortality specific over-accrual for men (P =. 001). Whites, Asians, Blacks, and Hispanics represented 91.7%, 1.5%, 2.6%, and 1.7% of trial participants. Compared with mortality, Blacks (47% of expected mortality, P =. 008), Hispanics (17% of expected mortality, P <. 001) and Asians (33% of expected mortality, P <. 001) were underrepresented compared with Whites (114% of expected mortality, P <. 001). Clinical trials meeting accrual benchmarks for race included minority authorship. Conclusions: Following the Revitalization Act, minorities and women remain underrepresented in therapeutic clinical trials for neuroepithelial tumors, relative to disease incidence and mortality. Study accrual has improved with time. This study provides a framework for clinical trial accrual efforts and offers guidance regarding workforce considerations associated with enrollment of underserved patients.

Original language	English (US)
Pages (from-to)	1341-1349
Number of pages	9
Journal	Neuro-oncology
Volume	24
Issue number	8
DOIs	https://doi.org/10.1093/neuonc/noac011
State	Published - Aug 1 2022

Keywords

clinical trial accrual
clinical trials
disparities
glioma

ASJC Scopus subject areas

Oncology
Clinical Neurology
Cancer Research

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10.1093/neuonc/noac011

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Reihl, S. J., Patil, N., Morshed, R. A., Mehari, M., Aabedi, A., Chukwueke, U. N., Porter, A. B., Fontil, V., Cioffi, G., Waite, K., Kruchko, C., Ostrom, Q., Barnholtz-Sloan, J., & Hervey-Jumper, S. L. (2022). A population study of clinical trial accrual for women and minorities in neuro-oncology following the NIH Revitalization Act. Neuro-oncology, 24(8), 1341-1349. https://doi.org/10.1093/neuonc/noac011

Reihl, SJ, Patil, N, Morshed, RA, Mehari, M, Aabedi, A, Chukwueke, UN, Porter, AB, Fontil, V, Cioffi, G, Waite, K, Kruchko, C, Ostrom, Q, Barnholtz-Sloan, J & Hervey-Jumper, SL 2022, 'A population study of clinical trial accrual for women and minorities in neuro-oncology following the NIH Revitalization Act', Neuro-oncology, vol. 24, no. 8, pp. 1341-1349. https://doi.org/10.1093/neuonc/noac011

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title = "A population study of clinical trial accrual for women and minorities in neuro-oncology following the NIH Revitalization Act",

abstract = "Background: The NIH Revitalization Act, implemented 29 years ago, set to improve the representation of women and minorities in clinical trials. In this study, we investigate progress made in all phase therapeutic clinical trials for neuroepithelial CNS tumors stratified by demographic-specific age-adjusted disease incidence and mortality. Additionally, we identify workforce characteristics associated with clinical trials meeting established accrual benchmarks. Methods: Registry study of published clinical trials for World Health Organization defined neuroepithelial CNS tumors between January 2000 and December 2019. Study participants were obtained from PubMed and ClinicalTrials.gov. Population-based data originated from the CBTRUS for incidence analyses. SEER-18 Incidence-Based Mortality data was used for mortality analysis. Descriptive statistics, Fisher exact, and χ2 tests were used for data analysis. Results: Among 662 published clinical trials representing 49 907 participants, 62.5% of participants were men and 37.5% women (P <. 0001) representing a mortality specific over-accrual for men (P =. 001). Whites, Asians, Blacks, and Hispanics represented 91.7%, 1.5%, 2.6%, and 1.7% of trial participants. Compared with mortality, Blacks (47% of expected mortality, P =. 008), Hispanics (17% of expected mortality, P <. 001) and Asians (33% of expected mortality, P <. 001) were underrepresented compared with Whites (114% of expected mortality, P <. 001). Clinical trials meeting accrual benchmarks for race included minority authorship. Conclusions: Following the Revitalization Act, minorities and women remain underrepresented in therapeutic clinical trials for neuroepithelial tumors, relative to disease incidence and mortality. Study accrual has improved with time. This study provides a framework for clinical trial accrual efforts and offers guidance regarding workforce considerations associated with enrollment of underserved patients.",

keywords = "clinical trial accrual, clinical trials, disparities, glioma",

author = "Reihl, {Sheantel J.} and Nirav Patil and Morshed, {Ramin A.} and Mulki Mehari and Alexander Aabedi and Chukwueke, {Ugonma N.} and Porter, {Alyx B.} and Valy Fontil and Gino Cioffi and Kristin Waite and Carol Kruchko and Quinn Ostrom and Jill Barnholtz-Sloan and Hervey-Jumper, {Shawn L.}",

year = "2022",

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doi = "10.1093/neuonc/noac011",

language = "English (US)",

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T1 - A population study of clinical trial accrual for women and minorities in neuro-oncology following the NIH Revitalization Act

AU - Reihl, Sheantel J.

AU - Patil, Nirav

AU - Morshed, Ramin A.

AU - Mehari, Mulki

AU - Aabedi, Alexander

AU - Chukwueke, Ugonma N.

AU - Porter, Alyx B.

AU - Fontil, Valy

AU - Cioffi, Gino

AU - Waite, Kristin

AU - Kruchko, Carol

AU - Ostrom, Quinn

AU - Barnholtz-Sloan, Jill

AU - Hervey-Jumper, Shawn L.

PY - 2022/8/1

Y1 - 2022/8/1

N2 - Background: The NIH Revitalization Act, implemented 29 years ago, set to improve the representation of women and minorities in clinical trials. In this study, we investigate progress made in all phase therapeutic clinical trials for neuroepithelial CNS tumors stratified by demographic-specific age-adjusted disease incidence and mortality. Additionally, we identify workforce characteristics associated with clinical trials meeting established accrual benchmarks. Methods: Registry study of published clinical trials for World Health Organization defined neuroepithelial CNS tumors between January 2000 and December 2019. Study participants were obtained from PubMed and ClinicalTrials.gov. Population-based data originated from the CBTRUS for incidence analyses. SEER-18 Incidence-Based Mortality data was used for mortality analysis. Descriptive statistics, Fisher exact, and χ2 tests were used for data analysis. Results: Among 662 published clinical trials representing 49 907 participants, 62.5% of participants were men and 37.5% women (P <. 0001) representing a mortality specific over-accrual for men (P =. 001). Whites, Asians, Blacks, and Hispanics represented 91.7%, 1.5%, 2.6%, and 1.7% of trial participants. Compared with mortality, Blacks (47% of expected mortality, P =. 008), Hispanics (17% of expected mortality, P <. 001) and Asians (33% of expected mortality, P <. 001) were underrepresented compared with Whites (114% of expected mortality, P <. 001). Clinical trials meeting accrual benchmarks for race included minority authorship. Conclusions: Following the Revitalization Act, minorities and women remain underrepresented in therapeutic clinical trials for neuroepithelial tumors, relative to disease incidence and mortality. Study accrual has improved with time. This study provides a framework for clinical trial accrual efforts and offers guidance regarding workforce considerations associated with enrollment of underserved patients.

AB - Background: The NIH Revitalization Act, implemented 29 years ago, set to improve the representation of women and minorities in clinical trials. In this study, we investigate progress made in all phase therapeutic clinical trials for neuroepithelial CNS tumors stratified by demographic-specific age-adjusted disease incidence and mortality. Additionally, we identify workforce characteristics associated with clinical trials meeting established accrual benchmarks. Methods: Registry study of published clinical trials for World Health Organization defined neuroepithelial CNS tumors between January 2000 and December 2019. Study participants were obtained from PubMed and ClinicalTrials.gov. Population-based data originated from the CBTRUS for incidence analyses. SEER-18 Incidence-Based Mortality data was used for mortality analysis. Descriptive statistics, Fisher exact, and χ2 tests were used for data analysis. Results: Among 662 published clinical trials representing 49 907 participants, 62.5% of participants were men and 37.5% women (P <. 0001) representing a mortality specific over-accrual for men (P =. 001). Whites, Asians, Blacks, and Hispanics represented 91.7%, 1.5%, 2.6%, and 1.7% of trial participants. Compared with mortality, Blacks (47% of expected mortality, P =. 008), Hispanics (17% of expected mortality, P <. 001) and Asians (33% of expected mortality, P <. 001) were underrepresented compared with Whites (114% of expected mortality, P <. 001). Clinical trials meeting accrual benchmarks for race included minority authorship. Conclusions: Following the Revitalization Act, minorities and women remain underrepresented in therapeutic clinical trials for neuroepithelial tumors, relative to disease incidence and mortality. Study accrual has improved with time. This study provides a framework for clinical trial accrual efforts and offers guidance regarding workforce considerations associated with enrollment of underserved patients.

KW - clinical trial accrual

KW - clinical trials

KW - disparities

KW - glioma

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A population study of clinical trial accrual for women and minorities in neuro-oncology following the NIH Revitalization Act

Abstract

Keywords

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