Tanzania
Research Article
A Simple Method for Estimating Confidence Intervals for Exposur e Adjusted Incidence Rate and Its Applications to Clinical Trials
Author(s): Xin He, Li Chen, Lei Lei, H. Amy Xia and Mei-Ling Ting LeeXin 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 .. Read More»
DOI:
10.4172/2155-6180.1000238
Journal of Biometrics & Biostatistics received 3254 citations as per Google Scholar report