Top 10 Tips For Diversity Plans

In June 2024, the FDA issued updated guidance to enhance diversity in clinical trials, emphasizing the development of comprehensive Diversity Action Plans. These plans are designed to address various dimensions of diversity, extending beyond age, ethnicity, sex, and race. Sponsors are required to set clear goals for enrolling diverse populations, informed by the disease's epidemiology across different groups. Study designs and eligibility criteria must be inclusive, with strategic site selections in areas with high concentrations of underrepresented groups to facilitate participation. The guidance underscores the importance of utilizing diverse data sources, including real-world data, to justify enrollment targets and address gaps in epidemiological data. Additionally, forming strategic partnerships with experts in epidemiology and clinical trial diversity is recommended to bolster diversity action plans and achieve representative enrollment.