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power-and-sample-size

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Computes sample size and power for clinical trials including continuous, binary, and time-to-event endpoints; superiority, non-inferiority, and equivalence designs; FDA 2016 non-inferiority margin selection with M1/M2 framework; Schoenfeld 1981 and Lakatos 1988 for survival; Schuirmann TOST and 80-125% bioequivalence; minimum clinically important difference (MCID) vs δ distinction. Use when justifying trial size in protocol or SAP per CONSORT 2025 item 16a.

When to use

• sample size and power for clinical trials
• continuous, binary, and time-to-event endpoints
• superiority, non-inferiority, and equivalence designs
• FDA 2016 non-inferiority margin selection
• Schoenfeld 1981 and Lakatos 1988 for survival
• Schuirmann TOST and 80-125% bioequivalence
• minimum clinically important difference (MCID) vs δ distinction
• justifying trial size in protocol or SAP per CONSORT 2025 item 16a

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