JSM 2005 - Toronto

Abstract #304353

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 57
Type: Topic Contributed
Date/Time: Sunday, August 7, 2005 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #304353
Title: Estimations of Treatment Effects on Multiple Endpoints for Clinical Trials with Interim Analyses
Author(s): Michael Lee*+ and Hui Quan
Companies: Merck Research Laboratories and Merck Research Laboratories
Address: P O Box 2000, Rahway, NJ, 07065, United States
Keywords: early stopping ; correlated endpoints ; confidence interval coverage ; estimation bias ; group sequential desings
Abstract:

Clinical trials with group-sequential design often are conducted to monitor treatment effects on trial endpoints. A trial with group-sequential design can be stopped early if the treatment effects can be demonstrated through interim analyses based on prespecified stopping rules. In addition to the need for Type-I error rate control for group-sequential-designed trials, appropriate estimates of treatment effects on the trial endpoints when the trials are stopped also are necessary. It is well known that the naïve estimates are biased. For a single endpoint trial, a few methods have been proposed in the literature about how to reduce the estimation bias and obtain confidence intervals for the treatment effects with proper coverage. In this research, we propose methods for adjusted estimations of treatment effects for group-sequential-designed trials in which treatment effects on correlated endpoints are evaluated. In addition, we consider the estimations of treatment effects on secondary endpoints when trial monitoring focuses on a primary endpoint. Simulations will be conducted to evaluate the performances of the methods.


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Revised March 2005