Abstract #301164

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JSM 2003 Abstract #301164
Activity Number: 421
Type: Contributed
Date/Time: Wednesday, August 6, 2003 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #301164
Title: An Application of Path Analysis in the Design of Clinical Trails
Author(s): Yili Lu*+
Companies: Eli Lilly & Company
Address: 9928 Redmond Ct., Indianapolis, IN, 46236-7367,
Keywords: path analysis ; structural equation analysis ; design of clinical trials
Abstract:

Path analysis, first developed in the field of genetics, refers to making a statistical inference regarding causality from postulated relationships developed from knowledge of subject matter (Retherford and Choe 1993). In the setting of clinical research, when developing a new chemical entity for two different indications for which the causal relationships between the two disease states are either not clear or confounded, to claim the independent treatment effect on one from the other is challenging. Prospectively defining path analysis in protocols can help to meet this challenge. In this approach, prespecified causal relationships are modeled by structural equations so that the treatment effect on the disease condition of interest (direct effect) will be tested after accounting for the treatment effect on the other conditions (indirect effects). This presentation will demonstrate what role path analysis can play in the circumstance, where clinical trials are designed to pursue a second indication while the first indication has already being established. Modeling details will be illustrated with data from clinical trials that studied antidepressant agent on patients with pain.


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