Economic Impact of Representativeness in Clinical Trials: How Real-World Data Can Help

This panel of real-world evidence (RWE) experts explore the economic impact and role of RWE in improving representativeness of research.

Despite the FDA guidance put forth in 2020 to enhance diversity in clinical trials, many populations remain underrepresented; particularly, racial and ethnic minority groups, women, and elderly individuals. This underrepresentation of disproportionately burdened groups limits information on therapeutic response, safety, and efficacy to a small subset of the population that tends to be healthier, more well-educated, and financially advantaged. Less than 20% of FDA drug approvals in the past 5 years had reported adverse effects or treatment benefits on Black participants¹.

Approvals based on limited data can have detrimental economic as well as clinical consequences. In a 2022 report from the National Academies of Science Engineering and Medicine, it is estimated that hundreds of billions of dollars will be lost in the US over the next 25 years due to the impacts of underrepresentation in clinical trials, specifically in chronic diseases such as diabetes, heart disease, and hypertension².

1) https://www.healthaffairs.org/doi/10.1377/hlthaff.2021.01432
2) https://healthpolicy.usc.edu/article/lack-of-diversity-in-clinical-trials-costs-billions-of-dollars-incentives-can-spur-innovation/