FDA Grand Rounds - Statistical Considerations for Drug Development in Rare Disease
FDA Center for Drug Evaluation and Research — Office of Biostatistics Grand Rounds · February 5, 2026
Natalie Morris, a statistician in the FDA Center for Drug Evaluation and Research Office of Biostatistics, presented methods and simulation results for adaptive trial designs in rare-disease drug development, highlighting adaptive treatment-duration designs as a widely applicable approach and urging simulations and prespecification to preserve trial integrity.
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