Increasing Diversity In Clinical Trials: 3 Steps For Sponsors

By Daenya McDonald, Marketing Director at CRIO

This past April, the FDA released updated guidance to sponsors and pharmaceutical companies on increasing racial and ethnic diversity in clinical trials to propel more inclusive research. Racial and ethnic minorities have historically been underrepresented in research^[1], even within diseases where they make up the majority of those affected. The FDA also advises sponsors to “seek diversity in clinical trial enrollment beyond populations defined by race and ethnicity, including other underrepresented populations defined by demographics such as sex, gender identity, age, socioeconomic status, disability, pregnancy status, lactation status, and co-morbidity.”^[2] This, in part, reflects a broader issue regarding inequitable access to health care and centers that conduct clinical research programs. Lack of awareness of clinical trials being conducted, transportation challenges, language barriers and mistrust within affected communities, all exacerbate this problem. Ultimately, diverse and inclusive study populations will help drive better outcomes across the entire population.