Abstract #300019

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JSM 2003 Abstract #300019
Activity Number: 179
Type: Contributed
Date/Time: Monday, August 4, 2003 : 2:00 PM to 3:50 PM
Sponsor: Biometrics Section
Abstract - #300019
Title: Including Multiple Imputation in a Sensitivity Analysis for Clinical Trials with Treatment Failures
Author(s): Michele Lee Shaffer*+ and Vernon M. Chinchilli
Companies: Pennsylvania State University and Pennsylvania State University
Address: 600 Centerview Dr., Hershey, PA, 17033-2902,
Keywords: Clinical trials ; intent-to-treat ; treatment failure ; repeated measures ; multiple imputation
Abstract:

When treatment failures occur during the course of a clinical trial, the treatment regimen following failure may be changed. This change in therapy complicates comparisons among the original treatment arms. As in clinical trials with dropouts, intent-to-treat analysis is not uniquely defined. We examine the use of multiple imputation to replace observations after treatment failure has occurred. As a sensitivity analysis, this approach is compared to existing methods for handling treatment failures--removing treatment failure subjects, removing data after the onset of treatment failure, and imputing the last observation prior to treatment failure for all subsequent observations--in addition to an analysis of the original data. A dataset from the Asthma Clinical Research Network is used to demonstrate the methods.

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