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.

part |2 pages

Section I: Background and Setting

chapter 1|2 pages


chapter 4|10 pages

Example Data

chapter 5|26 pages

Mixed-Effects Models Review

part |2 pages

Section II: Modeling the Observed Data

chapter 7|14 pages

Modeling Covariance (Correlation)

chapter 8|12 pages

Modeling Means Over Time

chapter 9|16 pages

Accounting for Covariates

chapter 10|10 pages

Categorical Data

chapter 11|8 pages

Model Checking and Verification

part |2 pages

Section III: Methods for Dealing with Missing Data

chapter 12|10 pages

Overview of Missing Data

chapter 14|8 pages

Direct Maximum Likelihood

chapter 15|30 pages

Multiple Imputation

chapter 17|12 pages

Doubly Robust Methods

chapter 18|16 pages

MNAR Methods

chapter 19|8 pages

Methods for Incomplete Categorical Data

part |2 pages

Section IV: A Comprehensive Approach to Study Development and Analyses

chapter 20|16 pages

Developing Statistical Analysis Plans

chapter 21|22 pages

Example Analyses of Clinical Trial Data