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Real-world data’s power to increase racial diversity in clinical research

Real-world data could help with step one of fixing racial disparities in clinical research

Real-world data has come into focus as one of the most important resources for accelerating drug development and defining the natural history of the disease during the pandemic, but it also represents one of the best tools available for addressing racial disparity in clinical research.

FDA has issued guidances and plans of action to address the issue over the past decade, but the lack of diversity in clinical trials remains a glaring problem across the biopharma industry. And Black patients are particularly underrepresented.

On average, Black subjects represent about 9% of participants in clinical trials for drugs that were approved last year by FDA’s Center for Drug Evaluation and Research (CDER), despite being over 13% of the overall U.S. population. But many of those participants are in trials for indications that predominantly or exclusively affect the Black community,

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