Lack of diversity in clinical trials costs billions of dollars. Incentives can spur innovation

The lack of diversity in clinical trials unfairly skews American medicine and costs billions of dollars a year in early deaths and poor health. The 2022 National Academies report showed that progress had been made on representation of white women in trials, but had stalled for people in underserved racial and ethnic populations. An analysis created for the NASEM report using the Future Elderly Model developed by the USC Schaeffer Center found that hundreds of billions of dollars will be lost over the next 25 years due to reduced life expectancy, shortened disability-free lives, and fewer years working among populations that are not proportionately represented in clinical trials.

If just 1% of health disparities were alleviated by improved diversity in clinical trials, the Schaeffer model estimates that would result in more than $40 billion in gains for diabetes and $60 billion for heart disease. Among its bundle of recommendations, the National Academies’ committee urged the FDA to study new inducements for sponsors that meet clinical trial representativeness criteria, including tax credits, fast-track eligibility, exemption from some FDA application fees, and extended market exclusivity for drugs. The National Academies report recommends that the Department of Health and Human Services, the FDA, the National Institutes of Health, and other federal agencies write new regulations and impose new requirements for diversity in clinical trials. The authors were members of the committee that wrote the National Academies of Sciences, Medicine, and Engineering report “Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups.”