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Abstract Details

Activity Number: 179
Type: Contributed
Date/Time: Monday, July 30, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #305829
Title: Evaluation of Overall Treatment Effect in MMRM
Author(s): Tao Song*+
Companies: Biogen Idec
Address: , , , United States
Keywords: Bias reduction ; MMRM ; Overall treatment effect ; Optimal weight ; Power
Abstract:

In longitudinal clinical trials for drug development, the study objective is often to evaluate overall treatment effect across all visits. As a direct likelihood method, Mixed-effects Model for Repeated Measures (MMRM) has become one of the preferred approaches for handling missing data in such designs. MMRM is a full multivariate model in nature, which avoids potential bias as a predetermined model and operates in a more general missing at random (MAR) framework. However, if treatment effect is constant over time, overparameterization of treatment by time interaction in MMRM could result in loss of power. In this presentation, we utilize MMRM estimates and propose an optimal weighting method for combining visit-specific estimates to maximize the power under MAR mechanism.


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