The patient population of clinical trials currently and historically have rarely represented the demographics of the general population. Real-world data (RWD) is increasingly being used to help address these disparities in trial participation. RWD sources are often far more diverse than patient pools available for physical clinical trial sites due to geographical and economic constraints.
According to , “In April 2022, the FDA issued draft guidance on developing formal diversity plans to improve enrollment of participants from underrepresented racial and ethnic populations in clinical trials. The guidance suggests that diversity plans begin with an assessment of any data that may show the potential for a product to have “differential safety or effectiveness associated with race or ethnicity.” The diversity plan guidance encourages sponsors to leverage a variety of data source – including published literature and RWD – to set enrollment goals.”
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(Source: Regulatory Focus, September 5th, 2022)