The U.S. Food and Drug Administration (FDA) has issued a 27-point action plan aimed at improving diversity in clinical trials. While the numbers of women participating in clinical trials has been increasing, racial and ethnic minorities apparently continue to be underrepresented. A law passed in 2012 required FDA to “take a closer look at the inclusion and analysis of demographic subgroups in applications for drugs, biologics and devices— including by sex, race and ethnicity, and age—and report” its findings. FDA issued its “Section 907” report to Congress in 2013 and, under the law, was required to complete an action plan one year later.
The 27 actions, many of which will involve collaboration with stakeholders and other government agencies over the next five years, are grouped under three priorities: “improving the completeness and quality of demographic subgroup data collection, reporting and analysis (quality); identifying barriers to subgroup enrollment in clinical trials and employing strategies to encourage greater participation (participation); and making demographic subgroup data more available and transparent (transparency).” Acknowledging that representation of diverse populations is beneficial “in applications for FDA-regulated medical products,” the action plan notes, “By improving data quality, encouraging greater participation in clinical trials, and making demographic subgroup data more available and transparent, we can help to ensure that researchers, health professionals and consumers will have easy access to meaningful clinical information about medical products that will help them make informed decisions.”