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multiplicity-graphical

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Implements multiplicity control for confirmatory clinical trials using graphical procedures (Bretz-Maurer-Hommel), gatekeeping (parallel, serial, mixed), Hochberg/Hommel/Holm with PRDS, and the closed-testing principle (Marcus-Peritz-Gabriel; Goeman 2021 admissibility). Covers FDA Multiple Endpoints Final Guidance (October 2022), graphical procedures via R gMCP, primary + key-secondary + subgroup hierarchies, and FWER vs FDR distinction. Use when designing the multiplicity strategy for confirmatory trials with multiple primary or key secondary endpoints.

When to use

• designing multiplicity strategy for confirmatory trials
• graphical procedures via R gMCP
• gatekeeping (parallel, serial, mixed)
• Hochberg/Hommel/Holm with PRDS
• closed-testing principle
• primary + key-secondary + subgroup hierarchies
• FWER vs FDR distinction
• FDA Multiple Endpoints Final Guidance

When not to use

• exploratory analysis
• FDR control for genomics or fMRI
• biomarker screens

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