Abstract #300676

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JSM 2003 Abstract #300676
Activity Number: 219
Type: Contributed
Date/Time: Tuesday, August 5, 2003 : 9:00 AM to 10:50 AM
Sponsor: ENAR
Abstract - #300676
Title: Probability Models and Computational Models for ANOVA in Multicenter Trials
Author(s): Thomas J. Permutt*+
Companies: Food and Drug Administration
Address: 6424 Fairest Dream Lane, Columbia, MD, 21044,
Keywords: clinical trials ; mixed effects
Abstract:

Many modern clinical trials of drugs involve multiple centers. Designs are typically partially balanced: within a center approximately equal numbers of patients are allocated to the various treatments, but different centers have different numbers of patients. The problem is to estimate and test the main effect of treatment. Mathematically, the problem is well studied, but the literature on interpretation has been mainly motivated by other applications, especially agriculture. Even though the usual assumptions of random-effects models are not satisfied in such trials, I believe that the least incorrect interpretation of the results entails assuming a random treatment-by-center interaction. Furthermore, mixed-effects estimators and tests may have desirable sampling properties even under fixed-effects probability models--more desirable, at least, than the most usual fixed-effects procedure.

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