JSM 2005 Online Program

Abstract #304611

This is the preliminary program for the 2005 Joint Statistical Meetings in Minneapolis, Minnesota. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 7-10, 2005); and Committee and Business Meetings. This on-line program will be updated frequently to reflect the most current revisions.

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Activity Number:	138
Type:	Contributed
Date/Time:	Monday, August 8, 2005 : 10:30 AM to 12:20 PM
Sponsor:	Biopharmaceutical Section
Abstract - #304611
Title:	Effects from Treatment Confounding Factors in Randomized Controlled Clinical Trials
Author(s):	Boll Wu*+ and Ray Zhu
Companies:	Sanofi-Aventis and Sanofi-Aventis
Address:	200 Crossing Blvd, Bridgewater, NJ, 08807, United States
Keywords:	clinical trials ; randomization ; confounding factors ; safety findings
Abstract:	In clinical trials, patients with the same prognostic or baseline disease factors can likely be allocated to different treatment groups with a slight degree of imbalance. When this happens to those factors that are highly associated with safety or efficacy outcomes, confounding arises to make it difficult in a direct interpretation of any between-cohort differences in the outcome. With real cases and clinical trial examples, identification of confounding factors and estimates of their impacts are presented. In these cases, safety "surprises" may not directly associate with new treatment, but rather can be a manifestation of some confounding background factors. Simple regression model is used to explore the likelihood of "interesting results" caused by confounding. Recommendations are discussed on trial design techniques to avoid confounding. Confounding identification and estimation methods also are discussed.

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