A population study of clinical trial accrual for women and minorities in neuro-oncology following the NIH Revitalization Act
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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 χ 2 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.
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In that neuro-oncology study, American Indian and Alaska Natives accounted for 1.3% of trial participants.
“and American Indian and Alaska Natives accounted for a mere 1.3% of trial participants [19].”
From Enablers and barriers of clinical trial participation in adult patients from minority ethnic groups: a systematic review (2025) · cites this paper as [19]
The Results section reports that American Indian/Alaska Native participants accounted for 0.2% of participants in studies reporting race. It assigns the 1.3% figure to Asian/Pacific Islander participants, not American Indian/Alaska Native participants. Page numbers were not provided in our copy. (LLM, conf=0.95)
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Experimental — accuracy not yet measuredIn that neuro-oncology study, Black and African Americans, Hispanic and Latino, and Asian and Pacific Islanders each accounted for less than 2.0% of trial participants.
“In contrast, minority ethnic groups such as Black and African Americans, Hispanic and Latino, and Asian and Pacific Islanders each accounted for less than 2.0% of trial participants”
From Enablers and barriers of clinical trial participation in adult patients from minority ethnic groups: a systematic review (2025) · cites this paper as [19]
The Results section reports Hispanic/Latino participants at 1.9% and Asian/Pacific Islander participants at 1.3%, both below 2.0%. It reports Black/African American participants at exactly 2.0%, not less than 2.0%; other accrual summaries in the paper give an even higher figure for that group. (LLM, conf=0.92)
Experimental — accuracy not yet measuredIn 2022, Reihl et al. found that almost 30 years after the Revitalization Act, White males were still overrepresented in neuro-oncology clinical trials, accounting for more than 90% of trial participants.
“In 2022, a study by Reihl et al. revealed that, almost 30 years after the Revitalization Act was put in place in the US, White males were still overrepresented in neuro-oncology clinical trials, accounting for more than 90% of trial participants.”
From Enablers and barriers of clinical trial participation in adult patients from minority ethnic groups: a systematic review (2025) · cites this paper as [19]
The Abstract reports that White participants accounted for 91.7% of trial participants, while men accounted for 62.5%; it does not say White men accounted for more than 90%. The Discussion says White men remained disproportionately represented in trials for adult neuro-epithelial CNS tumors, supporting the overrepresentation point but not the claimed percentage for that group. (LLM, conf=0.90)
Experimental — accuracy not yet measured
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Cites
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Alarcón Garavito, G. A., Gilchrist, K., Ciurtin, C., Khanna, S., Chambers, P., McNally, N., Merivale, E., Carr, E., Yu, R., & Vindrola-Padros, C. (2025) · Trials · doi:10.1186/s13063-025-08769-y · Cited by 42 · see citing works
“In contrast, minority ethnic groups such as Black and African Americans, Hispanic and Latino, and Asian and Pacific Islanders each accounted for less than 2.0% of trial participants, and American Indian and Alaska Natives accounted for a mere 1.3% of trial participants [19].”
Influential
- Authors
- 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.
- Affiliations
- University of California, San Francisco (US)
- University Hospitals of Cleveland (US)
- Harvard University (US)
- Mayo Clinic (US)
- San Francisco General Hospital (US)
- Central Brain Tumor Registry of the United States (US)
- Duke University (US)
- National Institutes of Health (US)
- Corresponding author
- Hervey-Jumper, Shawn L
- ORCID
- Venue
- Neuro-Oncology
- Publisher
- Oxford University Press (OUP)
- Published
- 2022-01-06
- Volume
- 24
- Issue
- 8
- Pages
- 1341-1349
- ISSN
- 1522-8517 (ISSN-L)
- 1523-5866
- PMC
- PMC9340618
- OpenAlex
- W4205780058
- Cited by
- 46
- References
- 13
- Citations by year
- 2026: 10 · 2025: 12 · 2024: 5 · 2023: 10 · 2022: 8 · 2021: 1
- FWCI
- 7.73
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
- Locations
- Neuro-Oncology (publishedVersion)
- medRxiv (acceptedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Funders
- National Institutes of Health
- National Center for Advancing Translational Sciences
- Neurosurgery Research and Education Foundation
- Robert Wood Johnson Foundation (74259, K08 110919-01)
- Centers for Disease Control and Prevention (75D30119C06056)
- American Brain Tumor Association
- The Sontag Foundation
- National Brain Tumor Society
- Pediatric Brain Tumor Foundation
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Social Sciences › Gender Studies › Diversity and Career in Medicine
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- clinical trial accrual, women in clinical trials, racial and ethnic minorities, brain tumors, underrepresentation, underserved patients, disease incidence and mortality
- MeSH terms
- Clinical Trials as Topic, Female, Humans, Male, Minority Groups, National Institutes of Health (U.S.), Neoplasms, Research Design, United States, Patient Selection
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