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Abstract Details

Activity Number: 253
Type: Contributed
Date/Time: Monday, July 30, 2012 : 2:00 PM to 3:50 PM
Sponsor: Biometrics Section
Abstract - #305830
Title: Effect of Compliance Interaction in Factorial Design on Standard Noncompliance Methods
Author(s): Peter D Merrill*+ and Leslie A McClure
Companies: The University of Alabama at Birmingham and The University of Alabama at Birmingham
Address: 3926 Asbury Park Lane, Birmingham, AL, 35243, United States
Keywords: Factorial Design ; Noncompliance ; Clinical Trials

Noncompliance with treatment assignment in a clinical trial is a common problem. Several methods have been developed to the end of estimating treatment effect in the presence of noncompliance, including intention-to-treat (ITT), instrumental variables (IV), and per-protocol (PP). In a 2x2 factorial design, participants are assigned to two treatments; this introduces the possibility of treatment assignment in one factor affecting the participant's compliance with treatment assignment in the other factor. The purpose of this study is to assess the effect of the presence and strength of a compliance interaction in a 2x2 factorial design when ITT, IV, and PP are used to estimate the main treatment effects through the use of simulations. The biases of the methods will be assessed across a range of compliance situations. We expect that stronger compliance interaction will lead to larger biases in the estimates of the treatment effects than if the factors were studied separately in two clinical trials.

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