Including multiple imputation in a sensitivity analysis for clinical trials with treatment failures

Michele L. Shaffer, Vernon M. Chinchilli

Research output: Contribution to journalArticlepeer-review

16 Scopus citations

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 some clinical trials with dropouts, intent-to-treat analysis can yield a large bias. 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 all collected data based on randomized treatment assignment. A data set from the Asthma Clinical Research Network is used to demonstrate the methods.

Original languageEnglish (US)
Pages (from-to)130-137
Number of pages8
JournalContemporary Clinical Trials
Volume28
Issue number2
DOIs
StatePublished - Feb 2007

All Science Journal Classification (ASJC) codes

  • Pharmacology (medical)

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