Master Protocols In Practice
Basket trials are building a path for tissue-agnostic drug development in oncology, and plans are proceeding for more master protocols in pediatric cancers, acute myeloid leukemia and pancreatic cancer.
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Woodcock Hopes I-SPY 2 Trial Is 'Blazing The Trail' For Future Adaptive Design Uptake
CDER director renews US FDA's support for complex trials, but acknowledges that sponsors are still hesitant to adopt them.
Master Protocols Are Both Welcome And Inevitable – US FDA's Woodcock
Center for Drug Evaluation and Research Director Janet Woodcock continues to promote innovation in clinical trial design with a review of master protocols in the New England Journal of Medicine.
Q&A: FDA Dx Reviewer's Tips For Next-Gen Sequencing Sponsors
A top reviewer in US FDA's in vitro diagnostics office offers tips to next-generation sequencing test sponsors to avoid common submission shortcomings in this interview with Medtech Insight. According to FDA's Hisani Madison, sponsors frequently fall short in providing a refined intended-use statement.