دورية أكاديمية
A population study of clinical trial accrual for women and minorities in neuro-oncology following the NIH Revitalization Act.
| العنوان: | A population study of clinical trial accrual for women and minorities in neuro-oncology following the NIH Revitalization Act. |
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| المؤلفون: | Reihl SJ; University of California, San Francisco, Department of Neurosurgery, San Francisco, California,USA., Patil N; Central Brain Tumor Registry of the United States (CBTRUS), Hinsdale, Illinois, USA.; University Health System, Research and Education Institute, Cleveland, Ohio, USA.; University Hospitals Health System, Research Health Analytics and Informatics, Cleveland, Ohio, USA., Morshed RA; University of California, San Francisco, Department of Neurosurgery, San Francisco, California,USA., Mehari M; University of California, San Francisco, Department of Neurosurgery, San Francisco, California,USA., Aabedi A; University of California, San Francisco, Department of Neurosurgery, San Francisco, California,USA., Chukwueke UN; Center for Neuro-Oncology, Dana-Farber Cancer Institute, Department of Neurology, Harvard Medical School, Boston, Massachusetts, USA., Porter AB; Mayo Clinic, Division of Neuro-Oncology, Department of Neurology, Phoenix, Arizona, USA., Fontil V; University of California San Francisco, Division of General Internal Medicine, San Francisco, California, USA.; University of California San Francisco, Center for Vulnerable Populations, Zuckerberg San Francisco General Hospital, San Francisco, California, USA., Cioffi G; Division of Cancer Epidemiology and Genetics, Trans-Divisional Research Program, National Cancer Institute, Bethesda, Maryland,USA.; Central Brain Tumor Registry of the United States (CBTRUS), Hinsdale, Illinois, USA., Waite K; Division of Cancer Epidemiology and Genetics, Trans-Divisional Research Program, National Cancer Institute, Bethesda, Maryland,USA.; Central Brain Tumor Registry of the United States (CBTRUS), Hinsdale, Illinois, USA., Kruchko C; Central Brain Tumor Registry of the United States (CBTRUS), Hinsdale, Illinois, USA., Ostrom Q; Central Brain Tumor Registry of the United States (CBTRUS), Hinsdale, Illinois, USA.; Department of Neurosurgery, Duke University School of Medicine, Durham, North Carolina, USA.; The Preston Robert Tisch Brain Tumor Center, Duke University School of Medicine, Durham, North Carolina, USA.; Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina, USA., Barnholtz-Sloan J; Central Brain Tumor Registry of the United States (CBTRUS), Hinsdale, Illinois, USA.; Center for Biomedical Informatics and Information Technology, National Cancer Institute, Bethesda, Maryland,USA., Hervey-Jumper SL; University of California, San Francisco, Department of Neurosurgery, San Francisco, California,USA. |
| المصدر: | Neuro-oncology [Neuro Oncol] 2022 Aug 01; Vol. 24 (8), pp. 1341-1349. |
| نوع المنشور: | Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.; Research Support, N.I.H., Extramural |
| اللغة: | English |
| بيانات الدورية: | Publisher: Oxford University Press Country of Publication: England NLM ID: 100887420 Publication Model: Print Cited Medium: Internet ISSN: 1523-5866 (Electronic) Linking ISSN: 15228517 NLM ISO Abbreviation: Neuro Oncol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2010- : Oxford : Oxford University Press Original Publication: 1999-<2002> : Charlottesville, VA : Carden Jennings Pub., |
| مواضيع طبية MeSH: | Clinical Trials as Topic* , Neoplasms*/therapy , Patient Selection*, Female ; Humans ; Male ; Minority Groups ; National Institutes of Health (U.S.) ; Research Design ; United States |
| مستخلص: | 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. (© The Author(s) 2022. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.) |
| التعليقات: | Comment in: Neuro Oncol. 2022 Mar 23;:. (PMID: 35325224) |
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| معلومات مُعتمدة: | K08 NS110919 United States NS NINDS NIH HHS; 75D30119C06056 United States CC CDC HHS; TL1 TR001871 United States TR NCATS NIH HHS |
| فهرسة مساهمة: | Keywords: clinical trial accrual; clinical trials; disparities; glioma |
| تواريخ الأحداث: | Date Created: 20220109 Date Completed: 20220802 Latest Revision: 20230107 |
| رمز التحديث: | 20230107 |
| مُعرف محوري في PubMed: | PMC9340618 |
| DOI: | 10.1093/neuonc/noac011 |
| PMID: | 34999844 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1523-5866 |
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| DOI: | 10.1093/neuonc/noac011 |