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FDA Encourages Pediatric Master Protocols With Bayesian Approach

 
• By Michael Cipriano

Most trials currently use of frequentist statistics, but agency argues that Bayesian methods allow for better extrapolation.

Could drugmakers begin to more frequently explore the Bayesian approach into data extrapolation for pediatric product development?

The model was highly touted by FDA speakers at a Sept. 23 public workshop on pediatric master protocols cohosted by the agency and the University of Maryland Center of Excellence...

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