The course objective is to enable participants to better understand statistical methodologies associated with multiple testing in clinical studies undertaken within the regulatory environment.
The course topics subdivided by section are detailed below.
Section 1 (Level 1 Section 8)
- Stratified Analysis for Continuous Endpoints
- Inflation of the Type I Error
- How Multiplicity Can Arise?
- Bonferroni and Hochberg Corrections
- Regulatory View on Multiplicity
- Importance of Pre-Planning
- Avoiding Adjustment including Hierarchical Testing
- Subgroup Testing
- Interim Analysis
Section 2 (Level 2 Section 6)
- Recap Level 1, Section 8
- Golden Rule
- Reporting p-Values
- Combining Hierarchical and α-Splitting Methodologies
- Closed Testing with Case Studies
- Revisiting Workshop-Exercise Level 1, Section 8
- Exploratory Analyses
- Revisiting Interim Analyses