FDA statistician outlines adaptive trial designs to address rare-disease evidence gaps At FDA Grand Rounds, Natalie Morris of the agency's Office of Biostatistics reviewed adaptive clinical-trial designs for rare diseases, presenting simulations that show an adaptive treatment-duration approach can preserve type I error and offer similar power to a fixed two-year trial in some settings.

Natalie Morris from the FDA reveals groundbreaking adaptive trial designs that could revolutionize drug development for rare diseases, tackling significant evidence gaps in the process.

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