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Activity Number: 397
Type: Invited
Date/Time: Tuesday, August 2, 2016 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #318421 View Presentation
Title: Issues and Solutions Encountered in the Design of Trials for Rare Diseases
Author(s): Brenda Gaydos* and Karen Price and Bill Prucka
Companies: Eli Lilly and Company and Eli Lilly and Company and Eli Lilly and Company
Keywords: adaptive ; Bayesian ; case studies
Abstract:

Several case studies in orphan indications and pediatrics will be presented. The practical and statistical issues are similar, and they will be outlined. We will discuss the design and analyses methods that were assessed, and the key factors that led to the recommended design that was taken forward. Bayesian methods and adaptive designs were utilized in all examples.


Authors who are presenting talks have a * after their name.

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