Longitudinal data analysis (repeated measures) in clinical trials

Longitudinal data is often collected in clinical trials to examine the effe ct of treatment on the disease process over time. This paper reviews and su mmarizes much of the methodological research on longitudinal data analysis from the perspective of clinical trials. We discuss methodology for analysi ng Gaussian and discrete longitudinal data and show how these methods can b e applied to clinical trials data. We illustrate these methods with five ex amples of clinical trials with longitudinal outcomes. We also discuss issue s of particular concern in clinical trials including sequential monitoring and adjustments for missing data. A review of current software for analysin g longitudinal data is also provided. Published in 1999 by John Wiley & Son s, Ltd. This article is a US Government work;Ind is the public domain in th e United States.