Module I: Clinical Trials a Practical Guide to Design, Analysis, and Reporting
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
Alternative Trial Designs
- Crossover Trials
- Factorial Design
- Equivalence Trials
- Bioequivalence Trials
- Noninferiority Trials
- Cluster Randomized Trials
- Multicenter Trials
Basics of Statistical Analysis
- Types of Data and Normal Distribution
- Significance Tests and Confidence Intervals
- Comparison of Means
- Comparison of Proportions
- Analysis of Survival Data 235
Special Trial Issues in Data Analysis
- Intention-to-Treat Analysis
- Subgroup Analysis
- Regression Analysis
- Adjustment for Covariates
- Confounding
- Interaction
- Repeated Measurements
- Multiplicity
- Missing Data
- Interim Monitoring and Stopping Rules
Reporting of Trials
- Overview of Reporting
- Trial Profile
- Presenting Baseline Data
- Use of Tables
- Use of Figures
- Critical Appraisal of a Report
- Meta-Analysis
Module II: SAS® Programming in the Pharmaceutical Industry
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
Creating Clinical Trial Graphs
- Common Clinical Trial Graphs
- Scatter Plot
- Line Plot
- Bar Chart
- Box Plot
- Odds Ratio Plot
- Kaplan-Meier Survival Estimates Plot
Performing Common Analyses and Obtaining
- 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
Exporting Data- The Future of SAS Programming in Clinical Trials
- 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
Analysis of Stratified Data
- Introduction
- Continuous Endpoints
- Categorical Endpoints
- Time-to-Event Endpoints
- Tests for Qualitative Interactions
Multiple Comparisons and Multiple Endpoints
- Introduction
- Single-Step Tests
- Closed Testing Methods
- Fixed-Sequence Testing Methods
- Resampling-Based Testing Methods
- Testing Procedures for Multiple Endpoints
- Gatekeeping Strategies
Analysis of Safety and Diagnostic Data
- Introduction
- Reference Intervals for Safety and Diagnostic Measures
- Analysis of Shift Tables
Interim Data Monitoring
- 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