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

Abstract Details

Activity Number: 665
Type: Topic Contributed
Date/Time: Thursday, August 5, 2010 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #306616
Title: Sequential Conditional Tests for an Increasing Trend in a Sequence of Binomial Proportions with Applications to Safety Signal Detection
Author(s): Jie Chen*+
Companies: Abbott Laboratories
Address: 200 Abbott Park Road, Abbott Park, IL, 60064, USA
Keywords: Sequential probability ratio test ; Continuation odds ratio ; Local odds ratio ; Safety monitoring
Abstract:

Sequential safety monitoring of biopharmaceutical products is commonly carried out in clinical trials and post-approval safety surveillance for early detection of potentially increased risk of some targeted adverse events (AE) that might be associated with the use of a product. Recently proposed sequential monitoring methods include sequential probability ratio test (SPRT) and sequential generalized likelihood ratio (GLR) test. In this research, we extend the sequential GLR test to detecting the proportional change of two sequences of possibly non-homogenous Poisson processes by sequentially conditioning on the two margins and defining continuation and local odds ratios. Explicit formulas are further developed and computational implementation is provided for the two methods. The proposed methods are illustrated with an example in vaccine safety surveillance.


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