COVID-Era Trial Flexibilities, Equity Focus, Could Be Used To Reshape Cancer Study Enrollment
US FDA is open to keeping COVID-necessitated trial changes that may have had unexpected benefits. The agency is also looking at building on pandemic’s focus on health disparities and inequities to push for more generalizable and inclusive clinical trial designs.
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Final FDA guidance also suggests sponsors recruit representative populations and limit exclusions.
Companies like Bayer and AstraZeneca are seeing what a difference decentralization makes as CVS is rapidly expanding its clinical research business.
Minorities are more likely to participate in cancer clinical trials than white people, but they are less likely to get the chance to say yes, highlighting the importance of bringing studies to different locations if sponsors are to be successful at increasing diversity.