Abstract #300881

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JSM 2002 Abstract #300881
Activity Number: 396
Type: Topic Contributed
Date/Time: Thursday, August 15, 2002 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section*
Abstract - #300881
Title: Mixed-effects Modeling and Simulation of Longitudinal Clinical Trials with Informative Dropouts
Author(s): Ratna Ramaswamy*+ and S. Ouyang
Affiliation(s): Johnson & Johnson Pharmaceutical R&D and Johnson & Johnson Pharmaceutical R&D
Address: 920 Route 202 South, Raritan, New Jersey, 08869, U.S.A
Keywords: informative dropout ; modeling
Abstract:

In many therapeutical areas, analysis, design, and planning of longitudinal clinical trials are complicated by patient dropouts. These dropouts are usually informative in the sense that the probability of dropping out depends on the therapeutic outcome. Ignoring dropouts may cause large uncertainty of trial performance in planning future trials and unknown bias in the analysis results. Integrated modeling of symptom assessments and dropouts using mixed effects may provide a more realistic description of trial outcome. Through simulation the performance of future trials can be evaluated against competing trial designs. A case study is provided to illustrate the application.

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Revised March 2002