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Abstract Details

Activity Number: 3
Type: Invited
Date/Time: Sunday, July 29, 2012 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #303550
Title: Sensible Analysis Plans for Incomplete Longitudinal Clinical Trial Data
Author(s): Craig H Mallinclrodt*+
Companies: Eli Lilly and Company
Address: Lilly Corporate Center, Indianapolis, IN, 46285,
Keywords: missing data ; clinical trials ; sensitivity analyses

The National Research Council was commissioned by FDA to make recommendations on the prevention and treatment of missing data in clinical trials. The Panel's report was made public in late 2010. This presentation will focus on a case study from a clinical trial in depression to illustrate a practical appraoch consistent with the Panel's recommendations for handling missing data from continuous endpoints. Specifically, the robustness of the a priori specified likelihood-based primary analysis will be assessed using a variety of MNAR analyses and an inclusive modeling multiple imputation approach, along with influence and residual diagnostics for the primary analysis. A novel method of imputing missing data for both the drug and placebo groups from the placebo group will be presented both as a likely conservative MNAR analysis and as an alternative to BOCF to assess effectiveness

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