JSM 2005 - Toronto

Abstract #304110

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 149
Type: Luncheons
Date/Time: Monday, August 8, 2005 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #304110
Title: Sample Size Reestimation and Other Innovative Adaptive Designs in Clinical Trials
Author(s): Jeff Maca*+
Companies: Novartis Pharmaceuticals
Address: One Health Plaza, East Hanover, NJ, 07936, United States
Keywords: Adaptive ; Sample size re-estimation ; Trial Design
Abstract:

When designing clinical trials, information about the characteristics of the treatment may not be available at the desired level of precision, or there may be no directly relevant information available. This lack of information could cause a study to be designed with incorrect trial parameters or assumptions, and could cause a study to fail even in the case of a beneficial treatment. Therefore, it could be considered advantageous to design a study in such a way that the design parameters can adapt or change as information is gathered pertaining to the effect of the treatment. One clear adaptation would be to adjust the sample size as parameter estimates become updated with information collected from the study. However, there could be many other adaptations, such as changing hypothesis, treatments, or number of treatment groups. The practical issues pertaining to designing and running such a trial will be discussed.


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Revised March 2005