FDA issues guidance on enhancing clinical trial population diversity

Written by Ilana Landau, Editor

The US FDA has released a final guidance document detailing approaches that clinical trial sponsors could take to help enhance the diversity of trial populations, in order to make them more representative of populations most likely to use a drug or medical product if approved.   Health disparities, the importance and impacts of which have been underscored by the COVID-19 pandemic, reflect how different groups of individuals can experience greater disease burden or mortality etc., compared with other groups. Such disparities highlight the importance of studying new potential interventions in diverse trial cohorts, to understand differential benefits or risks amongst...

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