Журнал биометрии и биостатистики

A Simple Method for Estimating Confidence Intervals for Exposur e Adjusted Incidence Rate and Its Applications to Clinical Trials

Abstract

Xin He, Li Chen, Lei Lei, H. Amy Xia and Mei-Ling Ting Lee

Assessment of drug safety typically involves estimation of occurrence rate of adverse events. Most often, the crude percentage (subject incidence) is used to estimate adverse event rate. However, in some situations, the exposure adjusted incidence rate (EAIR) may be a more appropriate measure to account for the potential difference in the duration of drug exposure or the follow-up time among individuals. In this article, we establish the asymptotic properties of the EAIR under certain assumptions, and propose a general and simple approach for variance estimation and for calculating the confidence interval of the rate. Simulation studies are conducted to evaluate the performance of the proposed approach. The results show that the proposed procedures perform well for various scenarios of different follow-up patterns. Data from a clinical trial are used to demonstrate the application of the method. A SAS macro is provided in the appendix.