JSM 2011 Online Program

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Abstract Details

Activity Number: 500
Type: Topic Contributed
Date/Time: Wednesday, August 3, 2011 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #301906
Title: A Review of Covariate-Adjusted Endpoint Analysis
Author(s): Zhen Zhang*+
Companies: Abbott Vascular
Address: 3200 Lakeside Drive, Santa Clara, CA, 95054,
Keywords: randomized clinical trial ; covariate adjustment ; endpoint ; variable selection
Abstract:

In randomized clinical trials (RCT), it is often believed that the whole randomization process will eliminate all biases and provide an ideal situation for unconditional test of the treatment effect. However, recent literatures suggested that even in RCTs, covariate-adjusted endpoint analysis (CAEA), when used appropriately, can improve the accuracy of the estimate of the effect size and therefore boost power of the endpoint analysis. In our work, we first provide a thorough review of recent developments in CAEA. Next, through extensive and carefully designed simulations, we will demonstrate advantages as well as disadvantages associated CAEA. Last, we will illustrate through examples on how to incorporate CAEA in trial design.


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