Participation in clinical research among racial and ethnic minorities remains low, even though such groups now represent nearly 40 percent of the US population. Health disparities were laid bare during the COVID-19 pandemic, with ethnic and racial minorities significantly underrepresented in early vaccine trials despite being disproportionally impacted by the disease. As a 2022 National Academies report stated, “The lack of equitable representation in clinical trials compounds disparities in health and will cost the United States hundreds of billions of dollars.”

Despite decades of work and recent progress—including passage of the Food and Drug Omnibus Reform Act of 2023, which established legislative mandates for increasing clinical trial diversity—there remains a need for collective action across sectors and organizations to align on goals for system-wide, sustainable change. To that end, members of the four organizations with established leadership in advancing diversity in clinical trials—the Clinical Trials Transformation Initiative (CTTI), FasterCures, the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center), and the National Academies Forum on Drug Discovery, Development, and Translation—coordinated a series of convenings in 2023 to establish a path toward increased diversity in clinical trials.

This report details the actions organizations and sectors from across the enterprise can take to create a clinical trials enterprise that is diverse, equitable, inclusive, and accessible to all.