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

Abstract Details

Activity Number: 513
Type: Contributed
Date/Time: Wednesday, August 4, 2010 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #307825
Title: Comparing Proportions of Extremely Rare Events of Uncertain Status with Applications to Vaccine Safety Studies
Author(s): Hongyuan Cao*+ and Lisa M. LaVange and Joseph Heyse and Michael Kosorok
Companies: The University of North Carolina at Chapel Hill and The University of North Carolina at Chapel Hill and Merck Research Laboratories and The University of North Carolina at Chapel Hill
Address: Department of Statistics and Operations Research, Chapel Hill, NC, 27599,
Keywords: Poisson approximation ; vaccine studies
Abstract:

We generalize the logrank statistic to the extremely rare setting where only a small number of events are observed and the events have uncertain status. In this setting, the limiting distribution is not Guassian but, rather, a ratio of Poisson random variables. We borrow a Bayesian idea to develop a frequentist valid testing procedure for comparing the intensity difference between two populations. Both numerical and asymptotic properties of the procedure are studied. This testing procedure is applied to a post-market safety study of a vaccine.


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