FDA is going to release a list of "surrogate endpo
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Posted On: 06/26/2018 9:51:22 AM
FDA is going to release a list of "surrogate endpoints" for cancer trials. This should speed up the approval process.
https://endpts.com/fda-to-release-list-of-sur...20oncology
https://endpts.com/fda-to-release-list-of-sur...20oncology
Quote:
“This mirrors the FDA’s internal analysis, where we’ve found that Phase 1 trials that are based on an enrichment design – in other words, trials where the patients are selected for a treatment based on how their tumors express a specific biomarker — are associated with a significantly higher probability of demonstrating a clinical benefit than those that are not,” he added.
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