JSM 2003 Online Program

Abstract #301449

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Activity Number:	332
Type:	Contributed
Date/Time:	Wednesday, August 6, 2003 : 8:30 AM to 10:20 AM
Sponsor:	Biopharmaceutical Section
Abstract - #301449
Title:	Valid Use of Analysis of Covariance Under Nontextbook Conditions
Author(s):	Gregory T. Golm*+ and Devan V. Mehrotra
Companies:	Merck and Company and Merck Research Laboratories
Address:	322 Lorraine Ave., Oreland, PA, 19075-2019,
Keywords:	ANCOVA ; HIV vaccine ; interaction ; postrandomization
Abstract:	In a typical analysis of covariance (ANCOVA) for a clinical trial, it is assumed that all covariates to be included in the model are measured before study participants are randomized. Another assumption is that covariate effects are the same across treatment groups. We illustrate the validity of ANCOVA for both estimation and inference in settings where the above two assumptions are potentially violated, with particular reference to Phase I HIV vaccine trials. Simulations are used to quantify the gains in efficiency that can be attained by our proposed analyses.

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