| Description |
1 online resource (330 pages) |
| Series |
Chapman & Hall/CRC Biostatistics Series |
|
Chapman & Hall/CRC biostatistics series.
|
| Contents |
Cover; Half Title; Title Page; Copyright Page; Table of Contents; Preface; Acknowledgments; List of Tables; List of Figures; List of Code Fragments; Section I: Background and Setting; 1: Introduction; 2: Objectives and Estimands-Determining What to Estimate; 2.1 Introduction; 2.2 Fundamental Considerations in Choosing Estimands; 2.3 Design Considerations in Choosing Estimands; 2.3.1 Missing Data Considerations; 2.3.2 Rescue Medication Considerations; 2.4 Analysis Considerations; 2.5 Multiple Estimands in the Same Study; 2.6 Choosing the Primary Estimand; 2.7 Summary |
|
3: Study Design-Collecting the Intended Data3.1 Introduction; 3.2 Trial Design; 3.3 Trial Conduct; 3.4 Summary; 4: Example Data; 4.1 Introduction; 4.2 Large Data Sets; 4.3 Small Data Sets; 5: Mixed-Effects Models Review; 5.1 Introduction; 5.2 Notation and Definitions; 5.3 Building and Solving Mixed Model Equations; 5.3.1 Ordinary Least Squares; 5.3.2 Generalized Least Squares; 5.3.3 Mixed-Effects Models; 5.3.4 Inference Tests; 5.4 Impact of Variance, Correlation, and Missing Data on Mixed Model Estimates; 5.4.1 Impact of Variance and Correlation in Complete and Balanced Data |
|
5.4.2 Impact of Variance and Correlation in Incomplete (Unbalanced) Data5.5 Methods of Estimation; 5.5.1 Inferential Frameworks; 5.5.2 Least Squares; 5.5.3 Generalized Estimating Equations; 5.5.4 Maximum Likelihood; 5.6 Marginal, Conditional, and Joint Inference; Section II: Modeling the Observed Data; 6: Choice of Dependent Variable and Statistical Test; 6.1 Introduction; 6.2 Statistical Test-Cross-Sectional and Longitudinal Contrasts; 6.3 Form of Dependent Variable (Actual Value, Change, or Percent Change); 6.4 Summary; 7: Modeling Covariance (Correlation); 7.1 Introduction |
|
7.2 Assessing Model Fit7.3 Modeling Covariance as a Function of Random Effects; 7.4 Modeling Covariance as a Function of Residual Effects; 7.5 Modeling Covariance as a Function of Random and Residual Effects; 7.6 Modeling Separate Covariance Structures for Groups; 7.7 Study Design Considerations; 7.8 Code Fragments; 7.9 Summary; 8: Modeling Means Over Time; 8.1 Introduction; 8.2 Unstructured Modeling of Means Over Time; 8.3 Structured Modeling of Means Over Time; 8.3.1 Time as a Fixed Effect; 8.3.2 Time as a Random Effect-Random Coefficients Regression; 8.4 Code Fragments; 8.5 Summary |
|
9: Accounting for Covariates9.1 Introduction; 9.2 Continuous Covariates; 9.2.1 Baseline Severity as a Covariate; 9.2.2 Baseline Severity as a Response; 9.2.3 Choosing the Best Approach; 9.3 Modeling Categorical Covariates; 9.4 Covariate-by-Treatment Interactions; 9.4.1 Continuous Covariates; 9.4.2 Categorical Covariates; 9.4.3 Observed versus Balanced Margins; 9.5 Code Fragments; 9.6 Summary; 10: Categorical Data; 10.1 Introduction; 10.2 Technical Details; 10.2.1 Modeling Approaches; 10.2.2 Estimation; 10.3 Examples; 10.3.1 Binary Longitudinal Data; 10.3.2 Ordinal Model for Multinomial Data |
| Summary |
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 |
| Notes |
10.4 Code Fragments |
|
Print version record |
| Subject |
Clinical trials -- Longitudinal studies
|
|
MEDICAL -- Biostatistics.
|
|
MEDICAL -- Pharmacy.
|
|
Clinical trials
|
| Genre/Form |
Longitudinal studies
|
| Form |
Electronic book
|
| Author |
Lipkovich, Ilya
|
| ISBN |
9781351737692 |
|
1351737694 |
|
