JSM 2015 Preliminary Program

Online Program Home
My Program

Abstract Details

Activity Number: 160
Type: Invited
Date/Time: Monday, August 10, 2015 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #314200 View Presentation
Title: On Incremental Incidence Rates in Long-Term Cohort Safety Studies
Author(s): Girish Aras*
Companies: Amgen
Keywords: Cohort Safety studies ; Incremental Incidence Rates ; K-M estimation ; Event of Medical Interest ; Adverse Events ; Non-parametric test
Abstract:

In safety studies, the incremental incidence rate is a useful concept in evaluating risks related to adverse events of medical interest (EMI). We propose estimates for the incremental (say annual)incidence rates and describe their statistical properties. More importantly, we propose tests for the null hypothesis that the incremental incidence rates remain constant during the study against various alternative hypotheses, such as rates changing over the years or having a specific trend, say monotonic increasing or decreasing. In contrast with the existing methods that test constant hazard rates, the proposed method allows non-constant hazard within each year; therefore, it is especially useful for EMIs that have a seasonal occurrence pattern. This article explores and characterizes properties of these tests under various alternatives via theory and simulations. A numerical example based on a real long-term single cohort safety study is also provided to demonstrate the application and interpretation of the proposed tests. It also illustrates limitations of visually inspecting the rates, as opposed to formally testing them, to assert a causal link between exposure and adverse EMIs.


Authors who are presenting talks have a * after their name.

Back to the full JSM 2015 program





For program information, contact the JSM Registration Department or phone (888) 231-3473.

For Professional Development information, contact the Education Department.

The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.

2015 JSM Online Program Home