• Types of Data and Normal Distribution

• Significance Tests and Confidence Intervals

• Comparison of Means

• Comparison of Proportions

• Analysis of Survival Data  235

• Intention-to-Treat Analysis

• Subgroup Analysis

• Regression Analysis

• Adjustment for Covariates

• Confounding

• Interaction

• Repeated Measurements

• Multiplicity

• Missing Data

• Interim Monitoring and Stopping Rules

• Overview of Reporting

• Trial Profile

• Presenting Baseline Data

• Use of Tables

• Use of Figures

• Critical Appraisal of a Report

• Meta-Analysis

• Preparing and Classifying Clinical

• Importing Data

• Transforming Data and Creating Analysis

• Creating Tables and Listings

• Creating Tables

• General Approach to Creating Tables

• Using PROC TABULATE to Create Clinical Trial Tables

• Using PROC REPORT to Create Clinical Trial Tables

• Creating Continuous/Categorical Summary Tables

• Creating Adverse Event Summaries

• Creating Concomitant or Prior Medication Tables

• Creating a Laboratory Shift Table

• Common Clinical Trial Graphs

• Scatter Plot

• Line Plot

• Bar Chart

• Box Plot

• Odds Ratio Plot

• Kaplan-Meier Survival Estimates Plot

• Statistics

• Obtaining Descriptive Statistics

• Using PROC FREQ to Export Descriptive Statistics

• Using PROC UNIVARIATE to Export Descriptive Statistics

• Obtaining Inferential Statistics from Categorical Data Analysis

• Performing a 2x2 Test for Association

• Performing an NxP Test for Association

• Performing a Stratified NxP Test for Association

• Performing Logistic Regression

• Obtaining Inferential Statistics from Continuous Data Analysis

• Performing a One-Sample Test of the Mean

• Performing a Two-Sample Test of the Means

• Performing an N-sample Test of the Means

• Obtaining Time-to-Event Analysis Statistics

• Obtaining Correlation Coefficients

• General Approach to Obtaining Statistics

• Changes in the Business Environment

• Changes in Technology

• Changes in Regulations

• Changes in Standards

• Use of SAS Software in the Clinical Trial Industry

• Module III: Analysis of Clinical Trials Using SAS

Introduction

Continuous Endpoints

Categorical Endpoints

Time-to-Event Endpoints

Tests for Qualitative Interactions

• Introduction

• Single-Step Tests

• Closed Testing Methods

• Fixed-Sequence Testing Methods

• Resampling-Based Testing Methods

• Testing Procedures for Multiple Endpoints

• Gatekeeping Strategies

• Introduction

• Reference Intervals for Safety and Diagnostic Measures

• Analysis of Shift Tables

• Introduction

• Repeated Significance Tests

• Stochastic Curtailment Tests

• Introduction

• Case Studies

• Data Setting and Modeling Framework

• Analysis of Complete Growth Data

• Simple Methods and MCAR

• Available Case Methods

• Likelihood-Based Ignorable Analyses

• Multiple Imputations

• The EM Algorithm

• Categorical Data

• MNAR and Sensitivity Analysis