Diversity And Inclusion In Oncology Clinical Trials

By Erin Finot, MS, MBA, Vice President, Immuno-Oncology & Cell and Gene Therapy, IQVIA Biotech; and James Kyle Bryan, MD, Chief Medical Officer, IQVIA Biotech

Ensuring demographic diversity in clinical trial enrollments offers invaluable insights into how therapies function across all affected populations, enhancing access to promising care for underrepresented patients. Recognizing this, the FDA is moving towards mandating clinically relevant populations for pivotal trials. However, historical disparities persist, with many trials predominantly enrolling white males. To address this, the FDA has initiated diversity and inclusion programs and drafted guidance for sponsors to develop Race and Ethnicity Diversity Plans. Congress is also pushing for Diversity Action Plans for most pivotal trials.

Despite challenges, sponsors can implement diversity plans to enroll and retain clinically relevant participants, including minorities, older patients, and those with disabilities. Taking a proactive approach throughout the trial lifecycle, from design to recruitment, is crucial. We offer a comprehensive framework for developing FDA Diversity Plans and operationalizing diversity tactics, ensuring trials reflect diverse populations.