Abstract #301305

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JSM 2003 Abstract #301305
Activity Number: 179
Type: Contributed
Date/Time: Monday, August 4, 2003 : 2:00 PM to 3:50 PM
Sponsor: Biometrics Section
Abstract - #301305
Title: The Effects of Noncompliance on Therapeutical Equivalence Trials
Author(s): Dan Sheng*+ and Mimi Y. Kim
Companies: New York University and New York University Medical Center
Address: 650 First Ave., New York, NY, 10016-3240,
Keywords: equivalence trial ; noncompliance ; intent-to-treat ; binary outcome
Abstract:

The standard approach for analyzing a randomized clinical trial is based on intent-to-treat (ITT), where subjects are analyzed according to their assigned treatment group, regardless of actual adherence or compliance with the treatment protocol. For therapeutical equivalence trials, the common view is that the ITT approach makes it easier to show equivalence since treatment differences tend to be diminished. However, this view is overly simplistic and needs to be more formally investigated. We evaluate the effects of non-compliance on the design and analysis of equivalence trials with a binary outcome. We consider tests for equivalence based on the difference in proportions and ratio of proportions. Our results indicate that an ITT analysis will not always increase the ability to establish equivalence. The effects on the type I error rate and power of the study depends on various factors, including the patterns of noncompliance, the magnitudes of treatment effects and the margin of equivalence.

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