Sheantel J Reihl1, Nirav Patil2,3,4, Ramin A Morshed1, Mulki Mehari1, Alexander Aabedi1, Ugonma N Chukwueke5, Alyx B Porter6, Valy Fontil7,8, Gino Cioffi9,2, Kristin Waite9,2, Carol Kruchko2, Quinn Ostrom2,10,11,12, Jill Barnholtz-Sloan2,13, Shawn L Hervey-Jumper1. 1. University of California, San Francisco, Department of Neurosurgery, San Francisco, California,USA. 2. Central Brain Tumor Registry of the United States (CBTRUS), Hinsdale, Illinois, USA. 3. University Health System, Research and Education Institute, Cleveland, Ohio, USA. 4. University Hospitals Health System, Research Health Analytics and Informatics, Cleveland, Ohio, USA. 5. Center for Neuro-Oncology, Dana-Farber Cancer Institute, Department of Neurology, Harvard Medical School, Boston, Massachusetts, USA. 6. Mayo Clinic, Division of Neuro-Oncology, Department of Neurology, Phoenix, Arizona, USA. 7. University of California San Francisco, Division of General Internal Medicine, San Francisco, California, USA. 8. University of California San Francisco, Center for Vulnerable Populations, Zuckerberg San Francisco General Hospital, San Francisco, California, USA. 9. Division of Cancer Epidemiology and Genetics, Trans-Divisional Research Program, National Cancer Institute, Bethesda, Maryland,USA. 10. Department of Neurosurgery, Duke University School of Medicine, Durham, North Carolina, USA. 11. The Preston Robert Tisch Brain Tumor Center, Duke University School of Medicine, Durham, North Carolina, USA. 12. Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina, USA. 13. Center for Biomedical Informatics and Information Technology, National Cancer Institute, Bethesda, Maryland,USA.
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.
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.
Authors: Jean G Ford; Mollie W Howerton; Gabriel Y Lai; Tiffany L Gary; Shari Bolen; M Chris Gibbons; Jon Tilburt; Charles Baffi; Teerath Peter Tanpitukpongse; Renee F Wilson; Neil R Powe; Eric B Bass Journal: Cancer Date: 2008-01-15 Impact factor: 6.860
Authors: Eudocia Q Lee; Ugonma N Chukwueke; Shawn L Hervey-Jumper; John F de Groot; Jose Pablo Leone; Terri S Armstrong; Susan M Chang; David Arons; Kathy Oliver; Kay Verble; Al Musella; Nicole Willmarth; Brian M Alexander; Amanda Bates; Lisa Doherty; Evanthia Galanis; Sarah Gaffey; Thomas Halkin; Bret E Friday; Maryam Fouladi; Nancy U Lin; David Macdonald; Minesh P Mehta; Marta Penas-Prado; Michael A Vogelbaum; Solmaz Sahebjam; David Sandak; Martin van den Bent; Michael Weller; David A Reardon; Patrick Y Wen Journal: Neuro Oncol Date: 2019-09-06 Impact factor: 12.300
Authors: Kathryn M Field; Katharine J Drummond; Merve Yilmaz; Mark Tacey; Daniel Compston; Peter Gibbs; Mark A Rosenthal Journal: J Clin Neurosci Date: 2013-04-29 Impact factor: 1.961
Authors: Krissia M Rivera Perla; Oliver Y Tang; Shayla N M Durfey; Tito Vivas-Buitrago; Wendy J Sherman; Ian Parney; Joon H Uhm; Alyx B Porter; Heinrich Elinzano; Steven A Toms; Alfredo Quiñones-Hinojosa Journal: J Neurooncol Date: 2022-05-03 Impact factor: 4.130