Clinical Trials Arena December 11, 2024
While diversity has been an important topic in the clinical trial industry for many years, new guidance from the FDA has put the focus on action for 2025 and beyond.
Diversity in clinical trials has been the focus of numerous industry discussions in recent years. This is for good reason, since underrepresentation amongst participants is hindering the industry’s ability to understand the full safety and efficacy profile of novel therapeutics, creating limited empirical evidence with questionable generalizability.
This can have serious consequences for misrepresented patient subgroups, including restricted or delayed access to medical interventions. In 2019, the US Food and Drug Administration’s (FDA) decision to exclude cisgender women from an approved HIV intervention because of the sponsor’s failure to investigate...
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