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Activity Number: 353
Type: Contributed
Date/Time: Tuesday, August 11, 2015 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #317656
Title: Missing Data Methods When Analyzing a Phase III Trial in an Orphan Indication
Author(s): Changlu Liu* and Mark Baillie and Melanie Wright and Mouna Akacha
Companies: Novartis and Novartis and Novartis and Novartis
Keywords: Missing data ; Sensitivity analysis ; HA discussions
Abstract:

As health authorities (HA) are becoming increasingly concerned about the impact of missing data on clinical trial outcomes, it is important to consider the robustness of the assumptions when pre-specifying the statistical analysis of a trial. In this presentation, we show a case study of the challenges with dealing with missing data faced when analyzing a Phase III study in an orphan indication. We will discuss the primary and sensitivity analyses of the study in greater depth as well as present the trial results illustrating the robustness of the methodology selected. We will also discuss the challenges that arise due to the small sample sizes of the study and share our experience in discussing these methods with regulators.


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

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