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Simulation Of Clinical Scenarios Important To Support Adaptive Trial Designs

 
• By Cathy Dombrowski

FDA has approved one drug supported by an adaptive design, but the trial did not save money or time, FDA statistician tells regulatory professionals.

SEATTLE – When considering an adaptive trial design proposal, FDA wants to see simulation studies that consider different scenarios for the variable components of the alternative clinical trial as support for the experimental protocol.

“It’s always necessary to conduct” a simulation study to support an adaptive design, Sue Jane Wang, associate director of adaptive design and pharmacogenomics at the Center for Drug Evaluation and...

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