Woodcock Hopes I-SPY 2 Trial Is 'Blazing The Trail' For Future Adaptive Design Uptake
Executive SummaryCDER director renews US FDA's support for complex trials, but acknowledges that sponsors are still hesitant to adopt them.
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Pathologic complete response eventually may be a surrogate endpoint for survival, but researchers and the US FDA outlined several problems that must be resolved first.
Public meeting scheduled for November to seek recommendations for policies that FDA could implement short-term to promote drug development programs.