JSM 2005 - Toronto

Abstract #304067

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Activity Number: 124
Type: Topic Contributed
Date/Time: Monday, August 8, 2005 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #304067
Title: 'Responder Analysis' of Clinical-relevant Evidence of Trials
Author(s): Yi Tsong*+
Companies: U.S. Food and Drug Administration
Address: 12720 Twinbrook Parkway, Rockville, MD, 20850, United States
Keywords: Clinical Trial ; responder analysis
Abstract:

In clinical trial, the benefit of a test treatment needs to be established not only by rejecting the null hypothesis of a regular significance test but also by demonstrating a clinical benefit of a meaningful size. For outcomes of normal distributions of equal variance for test and control treatments, Keiser et al. (2004) and others in the literature recommend to test if the mean difference is larger than K, a prespecified size of clinically meaningful benefit. A generalization of the definition is to define a responder rate of treatment A (in comparison to treatment B) as PA = Pr(XA - XB > K). A significance test with clinically meaningful benefit K can be performed by test H0: PT = PC versus Ha: PT > PC. An asymptotic test of normal response variables without common variance can be derived with Taylor's expansion (Walter 2002). Bootstrap method may be applicable for nonnormal response outcome variables. Properties of the proposed approach will be discussed.

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Revised March 2005