Course Details

One day classroom course with a mix of presentations and workshop sessions

The Course is designed to equip the delegate with an understanding of the key components of Clinical Trial Design. This also includes an explanation of the critical statistical aspects of trial design while assuming no prior knowledge.

Anyone involved in the design of clinical trials including

• Investigators
• CRAs
• Project Managers
• Medical Advisers

Trial Design Considerations 

• Parallel
• Cross Over
• Different Designs, incl Two Stage, Factorial, Group Sequential

Endpoints 

• Primary
• Multiple/Alternative and Co-primary
• Secondary
• Key secondary
• Surrogate

Superiority or Non-Inferiority 

• Definitions
• Success and Failure
• Selecting Margins
• Switching between Non-Inferiority and Superiority

Sample Size 

• Power
• Assumptions
• Entry criteria
• Implications
• Improving interactions with the statistician
• How it is done
  

Success Criteria 

• Statistical Significance
• p-value
• non-inferiority criteria

Interim Analysis 

• Statistical implications for interim analyses
• Adjustments for interim analyses
• Stopping rules, boundaries, efficacy, safety and futility

Multiple Comparisons and Alpha Spending 

• What is alpha?
• Why do we need to control alpha
• What is alpha spending

Bayesian vs Frequentist 

• What is the difference between Bayesian Trials and other trials?
• Bayes Theorem and the Bayesian Framework

Choice of Analysis Population 

• Which population is the correct one
• How do we select a population
• Intention to Treat, Modified ITT , Per protocol