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Episode 46, “The FDA Bayesian Guidance”
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In this episode of "In the Interim…", Dr. Scott Berry and Dr. Kert Viele deliver a quick reaction to the FDA’s draft guidance on Bayesian statistics for clinical trials of drugs and biologics.
The FDA's new Bayesian guidance is here, and it's a game-changer for clinical trial design. In our latest episode of "In the Interim…", Dr. Scott Berry and Dr. Kert Viele break down the FDA's draft guidance on Bayesian methodology for drugs and biologics.
Key takeaways:
• The FDA commissioner himself highlighted how Bayesian methods address high costs and long timelines
• The guidance makes a critical distinction between trials with Type I error control and those based on FDA agreement with Bayesian priors and decision rules.
• Dynamic discounting/borrowing is thoroughly discussed and endorsed, including a discussion of why strict type 1 error is not necessary.
• Pediatric-adult borrowing, hierarchical modeling of disease subtypes or subgroups, and phase 1 dose finding trials are all encouraged.
After decades of utilizing Bayesian methods but hearing naysayers throwing shade that FDA doesn’t like Bayesian methods, this guidance makes very clear – FDA is open and accepting of Bayesian methods. Listen now to be introduced to an exciting new era.
https://www.berryconsultants.com/resource/46-the-fda-bayesian-guidance
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Episode 46, “The FDA Bayesian Guidance”
In this episode of "In the Interim…", Dr. Scott Berry and Dr. Kert Viele deliver a quick reaction to the FDA’s draft guidance on Bayesian statistics for clinical trials of drugs and biologics.
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