Clinical Statistics

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Автор: Korosteleva O.

Название: Clinical Statistics: Introducing Clinical Trials, Survival Analysis, and Longitudinal Data Analysis

Издательство: Jones & Bartlett Learning

Год: 2009

Язык: английский

Формат: pdf

Размер: 48 Mb

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Clinical Statistics: Introducing Clinical Trials, Survival Analysis, and Longitudinal Data Analysis provides the mathematic background necessary for students preparing for a career as a statistician in the biomedical field. The manual explains the steps a clinical statistician must take in clinical trials from protocol writing to subject randomization, to data monitoring, and on to writing a final report to the FDA. All of the necessary fundamentals of statistical analysis: survival and longitudinal data analysis are included. SAS procedures are explained with simple examples and the mathematics behind these SAS procedures are covered in detail with the statistical software program SAS which is implemented throughout the text. Complete codes are given for every example found in the text. The exercises featured throughout the guide are both theoretical and applied making it appropriate for those moving on to different clinical settings. Students will find Clinical Statistics to be a handy lab reference for coursework and in their future careers.

Contents:

Conducting Clinical Trials.

Basic Concepts.

Phases of Clinical Trials.

Clinical Trials Management: Key Participants, Employee Documentation.

Preparation of Protocols.

Implementation of Statistics in Clinical Trials.

Determination of Trial Length.

Interim Data Monitoring:

Classical Group Sequential Testing, Bayesian Sequential Procedure.

Randomization of Group Assignments:

Principle of Similar-Sized Groups, Randomization Methods, Concealment of Group Assignments.

Data Reporting.

Introduction to Survival Analysis.

Basic Definitions.

Estimation of Survival Function by the Kaplan-Meier Method:

Definition of the Kaplan-Meier Estimator, Derivation of the Kaplan-Meier Estimator.

The Kaplan-Meier Survival Curve.

Comparison of Two Survival Functions: Log-Rank Test.

Estimation of the Survival Function by the Actuarial Method.

Parametric Estimation of the Survival Function:

Definition and Setup, Random Censoring Model, Exponential Distribution Model, Weibull Distribution Model.

Regression Model for Survival Time Distribution:

Exponential Regression Model, Weibull Regression Model, Model Fit Evaluation, Data Examples.

Cox Proportional Hazards Model:

Standard Definition, Estimation of Regression Coefficients, Interpretation of Regression Coefficients,

Alternative Form of the Cox Model, Exercises.

Introduction to Longitudinal Data Analysis.

Basic Definitions.

Graphical Presentation.

Random Intercept Model:

Model Definition and Interpretation of Coefficients, Estimation of Parameters, Data Example.

Random Slope and Intercept Model.

Model with Spatial Power Covariance Structure for Error.

Random Intercept Logistic Regression Model.

Handling Missing Observations:

Missingness Mechanism, Fitting Mixed-Effects Model to Unbalanced Data Sets, Data Example.

Exercises.

Recommended Books.