JSM 2015 Preliminary Program

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Activity Number: 617
Type: Contributed
Date/Time: Wednesday, August 12, 2015 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #316909 View Presentation
Title: Multiple Imputations for Missing Responder Endpoint
Author(s): Anjela Tzontcheva* and Susan Huyck
Companies: Merck and Merck
Keywords: Multiple Imputations ; binary endpoint ; Miettinen and Nurminen
Abstract:

In clinical trials with a binary primary endpoint (responder, non-responder), missing responses due to early patient discontinuation are often imputed with a non-responder value. This type of single imputation may lead to underestimation of uncertainty and bias the analysis. Multiple imputations (MI) can be employed as an alternative but in the case of binary response, normalizing transformations need to be used prior to combining MI-based estimates for overall inference using Rubin's rules as pointed out by Ratitch (2013). This talk is motivated by a Phase III clinical trial where the primary analysis of a responder endpoint is based on a stratified Miettinen and Nurminen method in which early drop-outs are analyzed as non-responders. Implementation of multiple imputation methods for binary response via standard SAS procedures will be presented and normalizing transformations for combining Miettinen and Nurminen estimates will be investigated.


Authors who are presenting talks have a * after their name.

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