References

Bierer, B. E., W. DeCormier Plosky, M. Hanger, E. Krofah, Y. Long, S. Mervin-Blake, and S. Okun. 2024. Toward a national action plan for achieving diversity in clinical trials. Washington, DC: The Milken Institute.

Buse, J. B., C. P. Austin, S. C. Johnston, F. Lewis-Hall, A. N. March, C. K. Shore, P. Tenaerts, and J. L. Rutter. 2023. A framework for assessing clinical trial site readiness. Journal of Clinical and Translational Science 7(1):e151.

CDC (U.S. Centers for Disease Control and Prevention). 2024. National Center for Health Statistics Health Insurance Coverage. https://cdc.gov/nchs/fastats/health-insurance.htm (accessed September 9, 2024).

CDC. 2023. Characteristics of mothers by source of payment for the delivery: United States, 2021. https://www.cdc.gov/nchs/products/databriefs/db468.htm (accessed September 9, 2024).

ClinicalTrials.gov. 2024. Comparison of in-home versus in-clinic administration of subcutaneous nivolumab through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) program (NCT06265285). https://clinicaltrials.gov/study/NCT06265285 (accessed September 9, 2024).

CMS (U.S. Centers for Medicare & Medicaid Services). 2024a. Historic 21.3 million people choose ACA Marketplace coverage. https://www.cms.gov/newsroom/press-releases/historic-213-million-people-choose-aca-marketplace-coverage (accessed September 9, 2024).

CMS. 2024b. CMS releases latest enrollment figures for Medicare, Medicaid, and Children’s Health Insurance Program (CHIP). https://content.govdelivery.com/accounts/USCMSMEDICAID/bulletins/38df7c8 (accessed September 9, 2024).

CMS. 2024c. National health expenditures fact sheet. https://www.cms.gov/data-research/statistics-trends-and-reports/national-health-expenditure-data/nhe-fact-sheet (accessed September 9, 2024).

CMS 2023. Coverage with evidence development proposed guidance document. https://www.cms.gov/files/document/proposed-ced-guidance-6-22-2023.pdf (accessed September 9, 2024).

Dzau, V. J., K. Mate, and M. O’Kane. 2022. Equity and quality—Improving health care delivery requires both. JAMA 327(6):519–520.

Federal Register. 2024. Revisions to OMB’s statistical policy directive no. 15: Standards for maintaining, collecting, and presenting federal data on race and ethnicity. Office of Management and Budget, 89 FR 22182: 22182-22196. https://www.federalregister.gov/documents/2024/03/29/2024-06469/revisions-to-ombs-statistical-policy-directive-no-15-standards-for-maintaining-collecting-and (accessed September 9, 2024).

Federal Register. 2022. Medicare program; transitional coverage for emerging technologies. Centers for Medicare & Medicaid Services, 89 FR 65724:65724–65754. (accessed September 9, 2024).

FDA (U.S. Food and Drug Administration). 2024a. Drug trials snapshots summary report 2023. https://www.fda.gov/media/178602/download?attachment (accessed September 9, 2024).

FDA. 2024b. Diversity action plans to improve enrollment of participants from underrepresented populations in clinical studies. https://www.fda.gov/media/179593/download (accessed September 9, 2024).

FDA. 2024c. Conducting clinical trials with decentralized elements guidance for industry, investigators, and other stakeholders. https://www.fda.gov/media/167696/download (accessed September 9, 2024).

FDA. 2023. Digital health technologies for remote data acquisition in clinical investigations guidance for industry, investigators, and other interested parties. https://www.fda.gov/media/155022/download (accessed September 9, 2024).

FDA. 2022. Diversity plans to improve enrollment of participants from underrepresented racial and ethnic populations in clinical trials guidance for industry. https://www.fda.gov/media/157635/download (accessed September 9, 2024).

FDA. 2020. Interacting with the FDA on complex innovative trial designs for drugs and biological products guidance for industry. https://www.fda.gov/media/130897/download (accessed September 9, 2024).

Grob, R., G. Darien, and D. Meyers. 2019. Why physicians should trust in patients. JAMA 321(14):1347–1348.

Harris, P. A., R. Taylor, B. L. Minor, V. Elliott, M. Fernandez, L. O’Neal, L. McLeod, G. Delacqua, F. Delacqua, J. Kirby, and S. N. Duda, on behalf of the REDCap Consortium. 2019. The REDCap Consortium: Building an international community of software platform partners. Journal of Biomedical Informatics 95:103208. https://doi.org/10.1016/j.jbi.2019.103208.

KFF. 2024. Medicaid State Fact Sheets. https://www.kff.org/interactive/medicaid-state-fact-sheets/ (accessed September 9, 2024).

Killian, J. A., M. Jain, Y. Jia, J. Amar, E. Huang, and M. Tambe. 2024. New approach to equitable intervention planning to improve engagement and outcomes in a digital health program: Simulation study. Journal of Medical Internet Research Diabetes 9:e52688.

March of Dimes PeriStats. 2024. Health insurance/income data for United States. https://www.marchofdimes.org/peristats/data?reg=99&top=11&stop=653&lev=1&slev=1&obj=1 (accessed September 9, 2024).

Mills, M. C., and C. Rahal. 2020. The GWAS Diversity Monitor tracks diversity by disease in real time. Nature Genetics 52:242–243.

NACHC (National Association of Community Healthcare Centers). 2024. Broadening research participation through community engagement. https://www.nachc.org/resource/report-broadening-research-participation-through-community-engagement/ (accessed September 9, 2024).

NASEM (National Academies of Sciences, Engineering, and Medicine). 2022. Improving representation in clinical trials and research: Building research equity for women and underrepresented groups. Washington, DC: The National Academies Press.

ONC (Office of the National Coordinator for Health Information Technology). 2024. Advancing health equity by design and health information technology: Proposed approach, invitation for public input, and call to action. https://www.healthit.gov/sites/default/files/2024-04/ONC-HEBD-Concept-Paper_508.pdf (accessed September 9, 2024).

OSTP (White House Office of Science and Technology Policy). 2022. Memorandum on ensuring free, immediate, and equitable access to federally funded research. https://whitehouse.gov/wp-content/uploads/2022/08/08-2022-OSTP-Public-access-Memo.pdf (accessed September 9, 2024).

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