Journal
JOURNAL OF BIOPHARMACEUTICAL STATISTICS
Volume 21, Issue 5, Pages 1006-1029Publisher
TAYLOR & FRANCIS INC
DOI: 10.1080/10543406.2010.520181
Keywords
Bayesian hierarchical models; Clinical trials; Drug safety; Multiplicity; Signal detection
Categories
Ask authors/readers for more resources
Detection of safety signals from clinical trial adverse event data is critical in drug development, but carries a challenging statistical multiplicity problem. Bayesian hierarchical mixture modeling is appealing for its ability to borrow strength across subgroups in the data, as well as moderate extreme findings most likely due merely to chance. We implement such a model for subject incidence (Berry and Berry, 2004) using a binomial likelihood, and extend it to subject-year adjusted incidence rate estimation under a Poisson likelihood. We use simulation to choose a signal detection threshold, and illustrate some effective graphics for displaying the flagged signals.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available