Analyzing Longitudinal Clinical Trial Data : A Practical Guide

Missing data in longitudinal clinical trials has justifiably been the target of considerable research. However, missing data is just one of the many considerations in the analysis of longitudinal data, and focus on the data we don’t have should not distract from focus on the data we do have. The statistical theory relevant to analyses of longitudinal data is extensive. However, the greatest difficulty may not be in knowing the theory, but rather in putting the theory into useful practice. Therefore, this book focuses on the most relevant and current theory for the common issues faced in planning and implementing analyses for longitudinal trials.

Analyzing Longitudinal Clinical Trial Data: A Practical Guide provides practical and easy to implement approaches for bringing the latest theory on analysis of longitudinal clinical trial data into routine practice.The book, with its example-oriented approach that includes numerous SAS and R code fragments, is an essential resource for statisticians and graduate students specializing in medical research.

The authors provide clear descriptions of the relevant statistical theory and illustrate practical considerations for modeling longitudinal data. Topics covered include choice of endpoint and statistical test; modeling means and the correlations between repeated measurements; accounting for covariates; modeling categorical data; model verification; methods for incomplete (missing) data that includes the latest developments in sensitivity analyses, along with approaches for and issues in choosing estimands; and means for preventing missing data. Each chapter stands alone in its coverage of a topic. The concluding chapters provide detailed advice on how to integrate these independent topics into an over-arching study development process and statistical analysis plan.