This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 409
Type: Contributed
Date/Time: Tuesday, August 3, 2010 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #307869
Title: Compare Sensitivity of Multiple Measures in Discerning a Treatment Effect
Author(s): Hongwei Wang*+ and Arvind K. Shah
Companies: Merck & Co., Inc. and Merck Research Laboratories
Address: RY34-A320, PO Box 2000, Rahway, NJ, 07065,
Keywords: multiple criteria ; sensitivity ; pairwise comparison ; bootstrap ; correlated endpoints

Multiple measures usually exist to reflect a patient's response to treatment. They usually have different characteristics and are moderately to highly correlated. An effective evaluation of their sensitivity in discerning a treatment effect could result in a substantial reduction of sample size required for a clinical trial. This evaluation needs to take the effect size and correlation structure into account which can be estimated from either a one-step procedure of multivariate analysis or a two-step procedure based on bootstrap. Further, the pairwise comparison among the multiple measures introduces the multiplicity issue which can be controlled using less stringent to more stringent criteria. Practical recommendation are given based on a detailed case study of an actual clinical trial data pool.

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