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Topic-Contributed Paper Session

New Methodological and Practical Approaches for Facilitating Drug Approvals in Rare Disease

Thu, Aug 10, 10:30 AM

Bradley CarlinChairBruno BoulangerOrganizer

Biopharmaceutical Section

4 Presentations

A Bayesian Divide-and-Conquer Approach for Using External Control Data in Rare Disease Clinical Trials

10:35 AM - 10:55 AM

Eric Baron (University of Connecticut)

Using INLA for Design and Analysis of Bayesian Adaptive Trials in Rare Disease

10:55 AM - 11:15 AM

Co-authors: Elias Krainski (KAUST), Haavard Rue (KAUST), Janet VanNiekerk (KAUST)

Learnings from Chronic Pain Master Protocol: FDA Complex Innovative Designs Pilot Program

11:15 AM - 11:35 AM

Shi Zhao (Eli Lilly and Company)

snSMART Design and Methods to Register a Drug in Rare Diseases

11:35 AM - 11:55 AM

Sidi Wang (University of Michigan)

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