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Toward a Framework to Improve Diversity and Inclusion in Clinical Trials: Proceedings of a Workshop (2024)

By: Theresa Wizemann, Kyle Cavagnini, Alex Helman, and Carolyn Shore

As stated in the 2022 National Academies of Sciences, Engineering, and Medicine (National Academies) report Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups, “An equitable clinical research enterprise would include trials and studies that match the demographics of the disease burden under study. However, we remain far from achieve this goal” (NASEM, 2022). Despite decades of work and ongoing efforts on the part of policy-makers, patient groups, nonprofits, and industry sponsors to improve racial and ethnic diversity in clinical trials, there has been little change over time (Dzau, 2022). Furthermore, inconsistencies in data collection and reporting makes it difficult to track progress of demographic group participation in the United States for clinical trials. Given the urgent need, there have been calls for collective action across sectors and organizations “to align on goals for system-wide sustainable change.”

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 can effectively take on alone (see Box 1-1). The workshop builds on meetings hosted by the Clinical Trials Transformation Initiative (CTTI) in June 2023, the Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard University in September 2023, and Faster- Cures of the Milken Institute in November 2023.

National Academies of Sciences, Engineering, and Medicine. 2024.