• Fundamentals of Trial Design

  • Randomized Clinical Trials
  • Uncontrolled Trials
  • Protocol Development
  • Endpoints
  • Patient Selection
  • Source and Control of Bias
  • Randomization
  • Blinding
  • Sample Size and Power

• Crossover Trials
• Factorial Design
• Equivalence Trials
• Bioequivalence Trials
• Non inferiority Trials
• Cluster Randomized Trials
• Multicenter Trials

• 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

Environment and Guiding Principles

• 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 2×2 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

Analysis of Stratified Data

• 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
• Analysis of Incomplete Data
• 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