US FDA’s Woodcock Sees Clinical Trial Reform Coming, But ‘Not Wholly Optimistic’
Acting FDA commissioner says there are a lot of strong forces in the research and pharma industries that could curb efforts to make pandemic-related clinical trial reforms permanent.
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Even though many approaches were successful, the agency may need a couple years to determine if the data generated were actionable.
Project Site Selector will allow FDA Oncology Center of Excellence staff to discuss site selection process with industry and potentially help improve clinical trial diversity efforts.
Final FDA guidance also suggests sponsors recruit representative populations and limit exclusions.