This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 626
Type: Contributed
Date/Time: Thursday, August 5, 2010 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #308156
Title: Power and Sample Size Calculations for Drug Exposure Registries Using Exact Methods
Author(s): Paul Schuette*+ and Eugenio Andraca-Carrera and Matthew Jackson and Benjamin Neustifter
Companies: FDA and FDA and FDA and FDA
Address: 10903 New Hampshire Avenue, Silver Spring, MD, 20903,
Keywords: Power and samples size ; Drug Eposure Registries ; exact methods
Abstract:

Many drug exposure registries employ asymptotic methods for determining power and sample size, although the validity of these methods for comparatively rare events is questionable, and may result in underpowered studies. If exact methods are used, then Chernick and Liu, 2002, have demonstrated that power as function of sample size for a single binomial proportion exhibits saw-toothed behavior. This lack of monotonicity can render the determination of the sample size for a given power problematic. We shall propose a resolution based on the fitting a lower envelope function to the saw-tooth power curve. We shall discuss methods for determining such a lower envelope, and the sensitivity and robustness of our methods. Finally, we shall extend our results from binomial proportions to Poisson rates.


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