471 – Innovations in Design and Analysis of Clinical Trials
Analytical Methodologies for Clinical Endpoint Data with Excessive Zero
Amarjot Kaur
Merck Research Laboratories
Jing Li
Merck
Ziliang Li
Merck
Nancy Liu
Merck
Zero-inflated normal or log-normal models have been introduced in literature for analyzing continuous data with high frequency of zeros and when the non-zero part of data approximately follow normal or log-normal distributions. However, the focus of available methods has primarily been on the estimations on the parameters of each separate model of the mixed-distribution. This article will discuss the estimation of the overall treatment effect along with its inferences entailing confidence intervals and p-values based on the zero-inflated log-normal model. The inferences based on zero-inflated normal model can be derived similarly. The zero-inflated log-normal model and the analysis of variance method will be compared using simulations and the rescue medication use data from an illustrative example study.
