{"id":3181,"date":"2024-06-10T11:22:31","date_gmt":"2024-06-10T15:22:31","guid":{"rendered":"https:\/\/cytel.agencyukdev.com\/perspectives\/fda-increases-calls-for-manufacturers-to-ensure-trial-diversity-but-does-it-fall-short-of-addressing-health-inequalities-in-product-development\/"},"modified":"2024-08-21T12:11:30","modified_gmt":"2024-08-21T16:11:30","slug":"fda-increases-calls-for-manufacturers-to-ensure-trial-diversity-but-does-it-fall-short-of-addressing-health-inequalities-in-product-development","status":"publish","type":"perspectives","link":"https:\/\/cytel.agencyukdev.com\/fr\/perspectives\/fda-increases-calls-for-manufacturers-to-ensure-trial-diversity-but-does-it-fall-short-of-addressing-health-inequalities-in-product-development\/","title":{"rendered":"FDA Increases Calls for Manufacturers to Ensure Trial Diversity, but Does It Fall Short of Addressing Health Inequalities in Product Development?"},"content":{"rendered":"

The evidence is staggering on the unequal health burdens experienced by specific patient groups defined by ethnic, gender, or socioeconomic risk factors and the different health outcomes these groups may have in clinical trials. And while efforts have been made to address these inequalities, they are still falling short. <\/p>\n

New FDA guidance: A significant step<\/strong><\/span><\/p>\n

Diversity, equity, and inclusion in trial development planning and enrollment practices are at the forefront of recent guidance from the United States Food and Drug Administration (FDA).1<\/sup>\u00a0This guidance is putting pressure on drug sponsors to ensure patients from underrepresented racial and ethnic groups are equally considered in clinical trials<\/span>. Using real-world data (RWD) in product development is a critical industry tool for revealing healthcare disparities across different communities and calling attention to the intercorrelations (intersectionality) between different levels of risk for these groups.<\/p>\n

The need for rich real-world data sources<\/strong><\/span><\/p>\n

The richer the RWD sources are, the more comprehensive the assessment of unequal health risk distribution.<\/span>2<\/sup>\u00a0This, in turn, can provide a more informative picture of the patients most clinically relevant to trial development programs. The increasing emphasis on using reliable, fit-for-purpose RWD in product development<\/span> would inevitably open the pathway to accelerate actions that promote equality, diversity, and inclusion in clinical trials.<\/p>\n

However, specific data and methodological challenges are not well addressed in this guidance<\/span>, including:<\/p>\n