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Activity Number: 424
Type: Contributed
Date/Time: Wednesday, August 9, 2006 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #305393
Title: What Is a Suitable Definition of Study Information in Longitudinal Clinical Trials?
Author(s): Guoguang Ma*+ and Michael Nessly
Companies: Merck & Co., Inc. and Merck Research Laboratories
Address: 10 Sentry Parkway, Blue Bell, PA, 19422,
Keywords: study information ; longitudinal trial
Abstract:

The total study information can be expressed either as the total number of patients or the total number of events in one sample problem. The repeated measurement setting, however, does not fit directly into this framework. The inverse of the variance of the estimated difference obtained at the planned end of the study is a logical choice. But it is dependent on the values of some unknown parameters. Wu and Lan (1992) introduced a surrogate information expression regarding the total number of measurements to be made as the total information. More recently, Kittelson et al. (2005) calculated the study information as a function of the covariance, the number of subjects, and the amount of follow up on each subject. In this work, we compare these approaches and discuss what could be a suitable definition of study information through simulation studies and a proof-of-concept study.


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