"Woodcock has for years promoted clinical trials that use "adaptive" designs like master protocols to test multiple experimental therapies quickly. Now, she says, there's tangible momentum behind adopting such ideas in R&D.
"I think we are past pure theory and we are in the early stages of the transformation," she said, mentioning some companies have talked with the FDA about setting up their own continuous or adaptive trials.
One trial that Woodcock highlighted is GBM AGILE, a study run by nonprofit brain cancer groups that aims to test various glioblastoma treatments. It's set to begin soon, and follows multiple late-stage trial failures in industry for the hard-to-treat, aggressive brain cancer."
https://www.biopharmadive.com/news/...-approval-biosimilars-clinical-trials/556161/
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