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Activity Number: 234
Type: Contributed
Date/Time: Monday, August 4, 2014 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #311851 View Presentation
Title: Identify a Target Population for Future Clinical Trial
Author(s): Aiyang Tao*+ and Lihui Zhao and Lee Jen Wei and Achim Guettner
Companies: Novartis and Northwestern University and Harvard and Novartis
Keywords: subgroup ; baseline covariate ; parametric scoring system
Abstract:

When for the treatment of chronic diseases, different dosages as well as different dosing intervals are compared, it is appealing if the efficacy is maintained while the treatment was given in longer intervals. The treatment comparison in a randomized clinical study is generally evaluated over study specific population. The treatment effect heavily relies on the choice of such a population. Treatment may not be effective for all patients. In this presentation, a parametric scoring system as a function of multiple baseline covariates is used to estimate subject-specific treatment differences. Based on this scoring system, a desired level of treatment difference and a subgroup of patients with certain baseline characteristics is identified, defined as those whose estimated scores within this threshold. An empirically calibrated threshold-specific treatment difference curve across a range of score values is constructed. The subpopulation of patients satisfying any given level of treatment benefit can then be identified accordingly which can be used for the future study design with longer interval treatment while the treatment effect is maintained as the shorter interval treatment


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