Abstract #302048

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JSM 2002 Abstract #302048
Activity Number: 335
Type: Luncheons
Date/Time: Wednesday, August 14, 2002 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section*
Abstract - #302048
Title: Accounting for Sites in the Analysis of Data from Multicenter Clinical Trials
Author(s): Paul Gallo*+
Affiliation(s): Novartis Pharmaceuticals
Address: One Health Plaza, East Hanover, New Jersey, 07936,
Keywords:
Abstract:

Questions regarding how clinical sites should be accounted for in analysis models for data from multicenter trials comprise an interesting, complex, and frequently controversial issue. Specific questions may include: whether center or treatment-by-center interaction should be routinely accounted for in primary analysis models; whether these should be considered fixed or random effects; whether artificial composite centers should be defined; how analysis results on treatment effects should be interpreted in the presence of apparent or possible interaction with site. These issues will be discussed not only in the linear model framework, which has been the basis for much of the historical discussion on this topic, but also for different types of analyses and more general data structures.

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JSM 2002

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Revised March 2002