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.
Designed For: Anyone involved in the design of clinical trials including
Trial Design Considerations
Different Designs, incl Two Stage, Factorial, Group Sequential
Multiple/Alternative and Co-primary
Superiority or Non-Inferiority
Success and Failure
Switching between Non-Inferiority and Superiority
Improving interactions with the statistician
How it is done
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