JSM 2005 Online Program

Abstract #304670

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:	391
Type:	Topic Contributed
Date/Time:	Wednesday, August 10, 2005 : 10:30 AM to 12:20 PM
Sponsor:	Biometrics Section
Abstract - #304670
Title:	Explanatory Analyses of Randomized Dose Response Trials with Direct and Indirect Effects
Author(s):	Long-Long Gao*+ and Marshall M. Joffe
Companies:	University of Pennsylvania and University of Pennsylvania
Address:	Room 505 Blockley Hall, Philadelphia, PA, 19104-6021, United States
Keywords:	Randomization ; Causal Inference ; Direct effect ; Indirect effect ; Clinical trial
Abstract:	Randomized trials are commonly conducted to evaluate certain treatment effects. Standard intention-to-treat (ITT) analysis is routinely performed to test if there is a significant difference in outcome between the randomized groups. In addition to ITT analysis, explanatory analyses often are conducted on randomized trial data to further address the reason for a difference between randomized groups or to examine effects of treatment received on the outcome. In this presentation, we use the concept of direct and indirect effects to enhance our understanding of explanatory analyses, and we employ G-estimation to estimate both direct and indirect effects under the structural nested models (Robins 1994). The concept and estimation approach are applied to a randomized dose-range study to further characterize the relationship between pharmacokinetics (PK) and pharmacodynamics (PD).

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