Toward a Framework to Improve Diversity and Inclusion in Clinical Trials Proceedings of a Workshop (2025) / Chapter Skim
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6 Challenging the Clinical Trial Ecosystem
6 Challenging the Clinical Trial Ecosystem
Pages 53-72
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(Dorsey) • Medicaid plans are now required to cover routine care costs for people participating in a qualifying clinical trial.
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(Adam, Nwokedi-Nwaneri) • As more clinical trials include locations outside of major ac ademic medical centers, there will be more "nontraditional investigators" and novel trial designs involved; FDA guidance documents are available to support the collection of quality data for regulatory submission.
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A PATIENT PERSPECTIVE ON TRUST AND ACCESS Gwen Darien, executive vice president of patient advocacy, engagement, and education at the Patient Advocate Foundation and member of the National Cancer Policy Forum, said there are "many patient advocates who are working toward equity and inclusion in clinical trials," and their voices are often missing from these discussions, including at the workshop. Darien is herself a three-time cancer survivor and believes her second and third cancers were an effect of late treatment of the first.
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In April 2022, before FDORA, Thanh Hai said FDA issued a draft guidance on Diversity Plans to Improve Enrollment of Underrepresented Racial and Ethnic Populations in Clinical Trials.3 FDA received an increasing number of diversity plans submitted voluntarily in response, which she said is encouraging because it shows that industry and other involved parties are engaged in improving diversity in clinical trials even before it is mandated. Thanh Hai also confirmed that "diversity action plans are here to stay; it's a statutory 1 The FDA draft guidance, Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies (FDA, 2024b)
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Thanh Hai referred participants to the CDER Center for Clinical Trial Innovation for more information about innovative designs that could help improve representation in clinical trials (e.g., decentralized trials, pragmatic trials, point-of-care trials, use of digital health) .5 PUBLIC–PRIVATE PARTNERSHIPS Stacey Adam, vice president for science partnerships at the Foundation for the National Institutes of Health (FNIH)
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SPONSORS BUILDING COMMUNITY CAPACITY Mary Nwokedi-Nwaneri, director of diversity in clinical trials at harmaceutical Research and Manufacturers of America (PhRMA) , said its P equity activities are built on three pillars: health equity (focusing on health systems management)
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This is an example of EQBMED trying to "maximize cross-collaboration of investments at these different sites that [are] already engaging with underrepresented communities in order to really maximize the effect of these different investments… to ensure that we're moving toward more of an infrastructure support or a foundation support to access individuals of color and meet them where they are within their communities." DIVERSITY IN DEVICE CLINICAL TRIALS DeChane Dorsey, executive director of AdvaMed Accel, the small company division of AdvaMed, discussed how the medical device trade association is working to improve health equity, including increasing diversity in device trials.
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In addition to these programs, 21 million people currently obtain coverage through the health care marketplace.10 Overall, 44 percent of children and 23 percent of adults have public insurance.11 This varies by race and ethnicity. For example, 65 percent of American Indian and Alaska Native children and 60 percent of Hispanic children are covered by Medicaid.12 In addition, Chalmers said that "Medicaid covers 41 percent of all births in the United States," and therefore clinical trials enrolling pregnant persons would likely include participants who have public insurance.13 Similarly, over 60 percent of children 8 As of November 2023 (CMS, 2024b)
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If clinical trials do not include sufficient representation of people with similar patterns of comorbidities, she said, the findings may require additional evidence development. McMurry-Heath noted that many FDA-approved trials do not meet those criteria, to which Chalmers responded that a team of CMS experts "looks at all the existing evidence of current therapies, all the new evidence and benefits, and makes that determination." MAKING THE BUSINESS CASE FOR DIVERSITY IN TRIALS During the discussion, panelists considered some of the challenges for product sponsors in meeting federal agency expectations for diversity and inclusion in clinical trials.
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She noted, "A better-informed and betterdeveloped product … gets to a larger segment of your potential p atient market." She also shared a concern that conversations about health equity in the clinical trials space can overlook medical devices in favor of drug development. AdvaMed is working with CMS and FDA to get more clarity around anti-kickback statutes and the Stark Law.
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As examples, she mentioned the FDA draft guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices,19 and final guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.20 FDA supports investigator training through engagement activities. Thanh Hai noted that she has met with fellows at Morehouse College of Medicine and at Stanford to discuss FDORA and diversity action plans.
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She suggested that HBCUs and other minority-serving institutions should be engaged at the start of research efforts to increase community engagement and ensure sustainability of clinical trial and clinical research workforce diversity. Thanh Hai said the FDA OND Research Participation Program conducts regulatory science and drug development research, hosts Oak Ridge Institute for Science and Education Fellows, who research under the mentorship of FDA scientists,23 and does outreach to HBCUs to inform students about this opportunity.
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However, it was felt that efforts to improve the diversity of clinical trials would generate the evidence needed to better serve the health needs of all patients and drive change in the health care system. • Understand the uniqueness of patients.
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Individuals and organi zations have been trying to address the lack of diversity in clinical trials from their perspective for a long time. But the importance of collaboration and partnership to share information and resources was a clear theme across the discussions, Lewis-Hall summarized.
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(Nwanyanwu) • Community health centers can be ideal partners in clinical trials because they serve populations most frequently excluded from trials and, in many cases, are already engaged or are interested in clinical trials, but their strained workforce and trust issues based on negative experiences with the clinical research enterprise remain barriers to participation.
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• As more clinical trials include locations outside of major academic medical centers, there will be more "nontraditional investigators" and novel trial d esigns involved; FDA guidance documents are available to support the collection of quality data for regulatory submission. (Thanh Hai)
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• Medicaid plans are now required to cover routine care costs for people participating in a qualifying clinical trial. Medicare coverage with evidence development covers items and services provided during participation in a CMS-approved clinical study when there is not yet sufficient evidence to sup port a national coverage decision.
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(Bumpus) • Approaches to improving race and ethnicity data collection and use include normalizing such collection to make it a routine part of the clinical trial process, screening for clinician bias in enrollment, and leveraging advanced data sci ence methodologies to improve equitable recruitment and assess clinical trial resource allocation.
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(Coylewright, Scholle, Washington) • Making clinical trial diversity data available to the public can help promote accountability.
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