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Adaptive Clinical Trials: US FDA Offers More Advice On Bayesian Designs

 
• By Brenda Sandburg

Final guidance provides more details on clinical trial designs that use Bayesian adaptive features; says monitoring committee recommendations may deviate from the anticipated algorithm.

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The US Food and Drug Administration's final guidance on adaptive clinical trial designs includes additional details on Bayesian design features and more flexibility in trial planning.

The guidance, Adaptive Designs for Clinical Trials of Drugs and Biologics, issued on 29 November, is nearly identical to the draft guidance published last year. However, at the request...

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