JSM 2005 - Toronto

Abstract #302837

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 349
Type: Topic Contributed
Date/Time: Wednesday, August 10, 2005 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #302837
Title: On the Treatment Effect in Clinical Trials with Dropout
Author(s): Bob Zhong*+ and Jun Shao
Companies: Centocor, Johnson and Johnson and University of Wisconsin, Madison
Address: 34288 N Haverton Dr, Gurnee, IL, 60031, United States
Keywords: Causal parameters ; study-end ; intention-to-treat ; MAR ; intention-to-treat ; last observation analysis
Abstract:

A patient's dropout often occurs in clinical trials with multiple scheduled visits, which results in a great challenge in the analysis of incomplete data. As the first step, one has to define a relevant treatment effect parameter, which is not straightforward in the presence of dropout. We discuss and compare three treatment effect parameters: the factual study-end treatment effect, the causal study-end treatment effect, and the last-observed treatment effect. Some related issues, such as the estimability of causal parameters, the dependence of study parameters on the dropout patterns, and the use of the last observation carry forward, also are discussed.


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