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clinical-trial-pipeline

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End-to-end clinical trial analysis workflow from CDISC SDTM/ADaM loading through ICH E9(R1) estimand-driven primary analysis to CONSORT 2025 regulatory-compliant reporting. Covers data preparation, FDA 2023 marginal vs conditional logistic regression, categorical tests with Boschloo, modern HTE/subgroup methods, missing-data sensitivity (MMRM, reference-based MI, Permutt tipping point), graphical multiplicity (Bretz-Maurer), survival analysis (Cox/RMST/competing risks) when applicable, and Table 1. Use when performing a complete analysis of clinical trial data.

When to use

• CDISC SDTM/ADaM loading
• ICH E9(R1) estimand-driven primary analysis
• CONSORT 2025 regulatory-compliant reporting
• FDA 2023 marginal vs conditional logistic regression
• Categorical tests with Boschloo
• Modern HTE/subgroup methods
• Missing-data sensitivity (MMRM, reference-based MI, Permutt tipping point)
• Graphical multiplicity (Bretz-Maurer)

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