Toward a Framework to Improve Diversity and Inclusion in Clinical Trials Proceedings of a Workshop (2025) / Chapter Skim
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1 Introduction
1 Introduction
Pages 1-8
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. On May 20, 2024, the National Academies Forum on Drug Discovery, Development, and Translation, in collaboration with the National Cancer Policy Forum, convened a public workshop to explore opportunities to improve racial and ethnic diversity with a focus on system-level change and collective efforts across organizations and sectors that no one entity 1 The planning committee's role was limited to planning the workshop, and the Proceedings of a Workshop has been prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop.
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TOWARD A NATIONAL ACTION PLAN To better align goals and drive collective, sustained efforts, members of four organizations with established leadership in increasing representation in clinical trials -- CTTI, Milken Institute FasterCures, MRCT, and the Forum on Drug Discovery, Development, and Translation -- coordinated a series of convenings to address the following aims as outlined by Barbara BOX 1–1 Workshop Statement of Task A planning committee of the National Academies of Sciences, Engineering, and Medicine will organize a public workshop to explore opportunities to improve racial and ethnic diversity in clinical trials with a focus on system-level change and collective efforts across organizations and sectors that no one entity can ef fectively take on alone. This workshop builds on previous meetings hosted by the Clinical Trials Transformation Initiative in June 2023, the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard in September 2023, and FasterCures in November 2023.
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• Learn together. • Drive accountability." Based on input from over 200 individuals representing academia, patient groups, federal agencies, industry, and communities; conversations at three convenings individually hosted by CTTI, MRCT, and F asterCures; information from questionnaires; and a literature analysis, a report c oauthored by CTTI, the Milken Institute, and MRCT, Toward a National Action Plan for Achieving Diversity in Clinical Trials (Bierer et al., 2024)
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4 IMPROVING DIVERSITY AND INCLUSION IN CLINICAL TRIALS BOX 1-2 National Action Plan Domains and Goals Public Awareness and Communication GOAL: "Create a sustainable, scalable, and measurable national campaign with involvement of historically underrepresented people and communities and the clinical trial ecosystem to increase awareness of and representativeness in clinical trials." Community Engagement and Investment GOAL: "Establish sustainably funded, enduring community partnerships, communi cation, and engagement to support clinical research that matters to communities." Site Enablement GOAL: "Enable more research sites, including community practices, to develop or increase their capacity to conduct clinical trials." Workforce Diversity GOAL: "Cultivate and provide long-term support for a representative clinical trials workforce." Trial Participation and Access GOAL: "Address barriers to clinical trial participation by taking actionable steps to reduce burdens and increase access." Funding, Resources, and Support GOAL: "Allocate funding resources for clinical trials to the appropriate study activities that are proven to increase diversity in clinical trials; identify and elimi nate structural financial barriers to participation." Comprehensive Data GOAL: "Establish a national (and international) , interoperable, and accountable sys tem for collecting and sharing condition-specific demographic and nondemographic data." Accountability GOAL: "Establish standardized outcome measures tailored at the organizational and national levels." SOURCES: Bierer and Hanger presentation, May 20, 2024; Bierer et al., 2024.
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Community Engagement and Investment Community engagement and investment are essential to develop effective messaging and communication strategies and support clinical research that is of value to the community, Bierer stated. It may be challenging for organizations to establish enduring community partnerships and shift investment models from one-off project-specific funding to sustainable long-term investments.
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Workforce Diversity Hanger recognized that work is already ongoing to support a more diverse and representative clinical trials workforce and the importance of starting early with efforts to increase public awareness and understanding of clinical research as a professional field. Additionally, she pointed to the need to establish a workforce pipeline, which includes training opportunities that underrepresented populations can access.
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Chapter 2 considers strategies for equitable participation in clinical trials, including how to scale existing efforts. In Chapter 3, panelists discuss defining, collecting, and sharing condition-specific demographic clinical trial data to facilitate continuous learning and accountability.
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