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trial-reporting

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Prepares statistical reports for clinical trials following CONSORT 2025, SPIRIT 2025, ICH E9(R1) estimands, and FDA 2023 covariate adjustment guidance. Covers Table 1 generation, analysis populations (ITT/FAS/PP/Safety), the 5 ICH E9(R1) intercurrent-event strategies, MMRM under MAR (mmrm), reference-based MI (rbmi J2R/CR/CIR), Permutt tipping-point sensitivity, and Rubin's-rules vs frequentist variance debate. Use when preparing regulatory submissions, defining estimands, or implementing missing-data sensitivity analyses.

When to use

• preparing regulatory submissions
• defining estimands
• implementing missing-data sensitivity analyses
• Table 1 generation
• analysis populations (ITT/FAS/PP/Safety)
• ICH E9(R1) intercurrent-event strategies
• MMRM under MAR
• reference-based MI (rbmi J2R/CR/CIR)

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