Issues and Approaches for the Analysis of Longitudinal Data in Confirmatory Clinical Trials
View Presentation *Craig H Mallinckrodt, Eli Lilly Keywords: longitudinal data, mixed-effects models, clinical trials Treatment effects are often evaluated by comparing change in outcomes over time. However, valid analyses of longitudinal data can be problematic. In choosing the primary hypothesis for confirmatory clinical trials, debate exists as to whether effectiveness or efficacy is most relevant. The pros and cons of each hypothesis will be discussed; leading to the conclusion that efficacy is most relevant. Given this hypothesis, the characteristics of the data can be used to quide development an appropriate analysis. These data characteristics and regulatory considerations will be reviewed. Theory and empirical evidence support the utility of a likelihood-based mixed-effects model repeated measures (MMRM) approach. Key aspects of the MMRM analysis will be contrasted with other formulations of mixed effects models.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC