Building Successful Diversity Initiatives In Clinical Trials Through Stakeholder Engagement

By Kelly McKee, VP, DCTs and Patient Registries

Despite ongoing regulatory and industry efforts, clinical trials often lack diversity, perpetuating inequitable access to innovative therapeutics. Historically, participants have been predominantly white and male, failing to represent real-world patient populations. Underrepresented groups, including ethnically/racially minoritized individuals, women, children, seniors, and socioeconomically disadvantaged populations, remain a challenge. For example, Black Americans, disproportionately affected by lung cancer, have low enrollment in relevant trials, limiting our understanding of treatment effects.

While there has been incremental progress, patient participation still falls short of the diverse treatment populations. New regulatory initiatives, such as the Consolidated Appropriations Act requiring diversity action plans for Phase 3 trials and the FDA's 2022 Diversity Plans Guidance emphasizing informed diversity goals, intensify pressure on sponsors to prioritize diversity initiatives. The recent ICH E8 Guidance internationally recognizes the importance of diversity, emphasizing the inclusion of participants representing diverse populations in later-stage drug development studies.

Review several pertinent barriers that have impeded diversity in clinical studies and the strategies used to overcome them.