3 – Recent Developments in Addressing Missing Data Issues in Clinical Trials
Sensible Approaches to Analyses of Incomplete Longitudinal Clinical Trial Data
Craig H. Mallinclrodt
Eli Lilly and Company
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.
