JSM 2004 - Toronto

Abstract #301301

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Activity Number: 156
Type: Contributed
Date/Time: Monday, August 9, 2004 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #301301
Title: Comparison of Methods of Missing-data Imputation in Analysis of Two Phase III Trials Treating HIV1 Infection
Author(s): Les Huson*+ and Jain Chung and Miklos Salgo
Companies: F. Hoffman La Roche and F. Hoffman La Roche and F. Hoffman La Roche
Address: Broadwater Way, Welwyn, International, , United Kingdom
Keywords: missing data ; imputation ; HIV1
Abstract:

In most longitudinal clinical trials, some patients drop out before the end of the planned follow-up, and, in order to allow an all-patient intent-to-treat analysis to be performed, it is common practice to use some method of imputation to estimate values for missing data. However, different imputation methods may give different results, and it is essential to investigate the sensitivity of the analysis using different imputation rules. Trials of treatment for HIV1 infection involve measurement of HIV1-RNA plasma values over time, and change from baseline in HIV1-RNA plasma concentration is a key measure of success. In our analysis of two trials of the new HIV1 fusion inhibitor enfuvirtide, we compared several methods of imputing and analyzing HIV1-RNA data, to check the robustness of the primary endpoint results. These were: (1) multiple imputation, (2) a nearest-neighbor hot-deck method, (3) censored regression analysis using last-observation-carried-forward, (4) last-observation-carried-forward using analysis of covariance, and (5) zero change from baseline (baseline-carried-forward).


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