SAS Clinical Training Course

  Part 1: Clinical Trials a Practical Guide to Design, Analysis and Reporting
Lecture -1 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

·   Practical Exercise

Lecture -2 Alternative Trial Designs 
·   Crossover Trials

·   Factorial Design

·   Equivalence Trials

·   Bioequivalence Trials

·   Noninferiority Trials

·   Cluster Randomized Trials

·   Multicenter Trials

·   Practical Exercise

Lecture -3 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

·   Practical Exercise

Lecture -4 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

·   Practical Exercise

Lecture -5 Reporting of Trials 
·   Overview of Reporting

·   Trial Profile

·   Presenting Baseline Data

·   Use of Tables

·   Use of Figures

·   Critical Appraisal of a Report

·   Meta-Analysis

·   Practical Exercise

  Part 2: SAS Programming in the Pharmaceutical Industry
Lecture -6 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

·   Practical Exercise

Lecture -7 Creating Clinical Trial Graphs 
·   Common Clinical Trial Graphs

·   Scatter Plot

·   Line Plot

·   Bar Chart

·   Box Plot

·   Odds Ratio Plot

·   Kaplan-Meier Survival Estimates Plot

·   Practical Exercise

Lecture -8 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

·   Practical Exercise

Lecture -9 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

·   Practical Exercise

  Part 3: Analysis Of Clinical Trials Using Sas
Lecture -10 Analysis of Stratified Data 
·   Introduction

·   Continuous Endpoints

·   Categorical Endpoints

·   Time-to-Event Endpoints

·   Tests for Qualitative Interactions

·   Practical Exercise

Lecture -11 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

·   Practical Exercise

Lecture -12 Analysis of Safety and Diagnostic Data 
·   Introduction

·   Reference Intervals for Safety and Diagnostic Measures

·   Analysis of Shift Tables

·   Practical Exercise

Lecture -13 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

·   Practical Exercise

  Case Studies