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Toward a Framework to Improve Diversity and Inclusion in Clinical Trials Proceedings of a Workshop (2025) / Chapter Skim
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3 Defining, Collecting, and Sharing Comprehensive and Consistent Data on Trial Diversity
Pages 21-30

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From page 21...
... • Many clinical and social services providers do not have the infrastructure needed to support demographic data collection or sharing. (Scholle)
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From page 22...
... • It is important to involve potential trial participants, providers, and other strategic partners when developing policies to guide meaningful and sustainable changes in diverse clinical trials. (Currie)
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From page 23...
... on optimizing data capture for clinical trials. Konya said this effort stems from the challenges faced during the COVID-19 pandemic in quickly initiating clinical trials across multiple sites and recruiting diverse patient populations.
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From page 24...
... She emphasized the role of leadership in making collecting race and ethnicity data an organizational priority. Scholle provided examples of how organizations are doing this, including the Centers for Medicare & Medicaid Services (CMS)
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From page 25...
... Finally, Verily is leveraging data gathered in clinical trial settings "to power more advanced data science methodologies for ensuring equitable participation in trials," Washington said. The availability of standardized data to power advanced algorithms can improve the ability to ensure that limited resources are effectively applied to achieve health equity goals.
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From page 26...
... Project Equity is also working to promote consistency and coordination of review practices, policies, research, and engagement internally across review divisions. Brewer said that FDA is "developing policies and guidances, fostering research and policy collaborations, incorporating diverse perspectives in regulatory ­activities across the Oncology Center of Excellence programmatic areas, and engaging with external stakeholders." ELEMENTS OF SUSTAINABLE CHANGE IN CLINICAL TRIAL DIVERSITY Michael Currie, a health care consultant and formerly chief health e­ quity officer at UnitedHealth Group, offered his perspective on four ele ments of promoting equitable representation in clinical trials.
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From page 27...
... Konya said it is a bit of both, based on the responses to the OSTP RFi and the subsequent engagements. Some responses to the RFi discussed issues with registering new or different trial sites, even though establishing new sites in communities where target populations live can reduce barriers to participation.
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From page 28...
... Also important, ­Washington said, is how agencies handle the absence of information; for example, CMS denied coverage for an early Alzheimer's treatment due to insufficient diversity in the trial population. He noted that "no one lever alone is sufficient to actually drive the change." Brewer said issues of ­insufficient data will persist if study sponsors keep using the same clinical sites when they know those sites lack the populations they need for diverse enrollment, describing it as "an unforced error of insufficient data." DATA ON WORKFORCE AND PROVIDER DIVERSITY Ann Taylor, former chief medical officer of AstraZeneca and cochair of the Forum on Drug Discovery, Development, and Translation, observed that having health care providers representative of the populations they serve can be a component of building trust, but no central or standardized processes exist for collecting, storing, or using these data.
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From page 29...
... " He said the Restless Multi-Armed Bandit framework can be used to assess resource allocation by identifying channels that are performing to deliver the desired outcome (e.g., a diverse clinical trial population) , and then directing more resources to support recruitment to that channel rather than deciding site funding levels up front based on community or practice demographics.
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Key Terms

  • clinical trial
  • ethnicity data
  • demographic data
  • accessed september
  • diverse clinical

  • data elements
  • health equity
  • sustainable change
  • trial data
  • enable data

  • advanced data
  • health plan
  • data science
  • data sharing
  • advancing health

  • support diverse
  • trial diversity
  • trial process
  • health information
  • trial participants

  • improve equitable
  • provider demographic
  • diverse patient
  • collecting race
  • equitable recruitment

  • organizational priority
  • provider race
  • patient populations
  • conduct clinical
  • clinical team


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