Toward a Framework to Improve Diversity and Inclusion in Clinical Trials Proceedings of a Workshop (2025) / Chapter Skim
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5 Agency Perspectives: CMS, FDA, and NIH
5 Agency Perspectives: CMS, FDA, and NIH
Pages 41-52
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From page 41... ...
. • Making clinical trial diversity data available to the public can help promote accountability.
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Shari Ling, deputy chief medical officer at the Centers for Medicare and Medicaid Services (CMS) , shared her perspective on opportunities for CMS contributions under its current authority in a conversation moderated by Esther Krofah, executive vice president for health for the Milken Institute and member of the Forum on Drug Discovery, Development, and Translation.
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CMS Opportunities to Stimulate and Transform Evidence Generation CMS has several tools to stimulate generation of evidence to support coverage determinations that might also be leveraged to increase the diversity of clinical trial data. Coverage Determinations Most CMS coverage determinations are made at the local level by Medicare contractors, Ling explained.
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From page 44... ...
One CMS tool for promoting quality and value is the merit-based incentive program for clinicians, which rewards providers for activities that improve care quality and outcomes. Clinicians are judged according to factors such as care quality, cost of care, promoting interoperability, and activities that improve clinical practice; these criteria were established through the CMS rulemaking process.
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From page 45... ...
Ling noted that the Office of the National Coordinator for Health Information is working on standards for interoperability of health-related data to enable sharing and delineating data elements for health-related social needs, social determinants of health, race, geography, ethnicity, and distinction from race.4 Other Opportunities Cost can be a barrier to clinical trial participation for some patients. This is exacerbated by a lack of clarity about insurance coverage for routine care elements of a trial and out-of-pocket cost sharing (e.g., copayments)
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From page 46... ...
Bertagnolli noted that, despite recent progress, representative inclusion of many other populations is still lacking, including Indigenous peoples, pregnant women, people who live in rural locations, people with disabilities, sexual and gender minorities, elderly people, and children. Bertagnolli stated that because NIH primarily invests in basic or dis covery science, the agency must be very strategic when funding clinical trials.
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Minority and Health Disparities Strategic Plan Including diverse populations should become the norm in all NIH research, Bertagnolli said. A goal of the NIH Minority and Health Disparities Strategic Plan is to increase the overall proportion of patients from diverse populations in NIH-funded research by an additional 40 percent by 2030.8 As one example of how NIH will achieve this, she said the agency is entering into clinical research partnerships with American Indian and Alaska Native tribes, Native Hawaiians, and Pacific Islanders through the Native American Research Centers for Health program, which will support care and clinical trials in those communities.9 FDA Perspective Califf agreed with Bertagnolli about progress toward increasing diversity in clinical trials and that areas for improvement remain, especially for the wider spectrum of underrepresented groups (e.g., older adults, rural populations)
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Other opportunities exist through the FDA Office of Minority Health and Health Equity, which provides funding for community engagement, including building infrastructure in communities to enable clinical trials, Bumpus said. Feedback from community development emphasizes the importance of fostering longer-term, deeper relationships with communities, beyond simply building trial capacity and enrolling community members.
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He pointed out that many of the data from industry-sponsored clinical trials of products in development are considered to be confidential commercial information, and CDER Drug Trials Snapshots only include drugs that have been approved by FDA. Given that 90 percent of investigational drugs that enter Phase 1 clinical studies are not approved and data from failed or otherwise suspended programs are not publicly shared, this can make it difficult for the clinical research system as a whole to learn from what did not work.
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Bertagnolli noted that a major challenge to high-quality research is insufficient capacity for quality clinical care in rural locations and communities that are undergoing "particular crisis of need." Bertagnolli and Jesse Nodora, associate director for Community Outreach and Engagement at Moores Cancer Center at the University of California, San Diego, pointed to the Native BioData Consortium, a non profit research institute led by U.S. Indigenous scientists and tribal members to enable Indigenous sovereignty over biosamples and data ownership.12 Bertagnolli said NIH is engaging with "Native American communities to develop ways that we can work effectively with these sovereign nations in order to advance health for everyone." That includes her support for the concept "nothing about us without us when it comes to biomedical research." She said that NIH is listening, engaging, and working with Tribal Nations, American Indian and Alaska Native populations, and Indigenous communities.
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AGENCY PERSPECTIVES: CMS, FDA, AND NIH 51 to be "representative of the people for whom the treatment is intended," not the population of the United States. Bierer noted the challenge that epidemiological data regarding the demographics of the impacted population are often lacking, "particularly by subpopulation and even worse by intersectionality."
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