JSM 2005 Online Program

Abstract #304202

This is the preliminary program for the 2005 Joint Statistical Meetings in Minneapolis, Minnesota. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 7-10, 2005); and Committee and Business Meetings. This on-line program will be updated frequently to reflect the most current revisions.

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Activity Number:	100
Type:	Contributed
Date/Time:	Monday, August 8, 2005 : 8:30 AM to 10:20 AM
Sponsor:	Biopharmaceutical Section
Abstract - #304202
Title:	Analysis of Time-to-event Data with Application to HIV Clinical Trials
Author(s):	Qiming Liao*+
Companies:	GlaxoSmithKline
Address:	5 Moore Drive, RTP, NC, 27709, United States
Keywords:	HIV clinical trials ; Left censoring ; Loss of virologic response ; Non-parametric estimate ; Right censoring ; Survival analysis
Abstract:	Time to loss of virologic response (TLOVR) often is a primary endpoint in most longterm HIV clinical trials. There are two types of loss of virologic response: HIV-1 RNA rebounding after initial response (rebounder) and no response at all (nonresponder) by a given period of treatment time (e.g., 24 weeks), after which subjects have to intensify with more drug(s), switch therapy, or discontinue the study. There are challenges to analysis of such time-to-event data. Virologically, which does better: early rebounder or nonresponder? One method was to consider all nonresponders as having reached an event at 0 (i.e., all rebounders are better than nonresponders virologically) and another method was to not distinguish all early rebounders and nonresponders. Then, they do typical survival analysis for observed- and right-censored TLOVR data. In this paper, we consider nonresponders as left-censored with fixed censoring bound, propose a nonparametric estimate method for survival function, and do regression analysis for such left- and right-censored data. We apply our methods to HIV clinical trials and an example will be presented.

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