Transcription of 臨床試験における症例数設定とガイドライン 5F 4F 5F
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臨床試験における症例数設定とガイドライン 5F 4F 5F
2016 (6 15 5F ) (7 27 5F ) (8 24 5F ) (11 2 4F 1) (11 16 5F ) (11 30 4F 1) (12 28 5F ) (2 1 4F 1) (2 22 5F ) (3 22 4F 1) p 40% Study AStudy B 40 , 20 ( ) p = ( ) 80 , 40 ( ) p = * ( ) Study A negative study Study B positive study Study A Positivestudy Study A Study B 80 (50%) 40 (55%) Study AStudy B80 40 ( ) The required sample size was estimated based on a threshold RR of 35% and an expected RR of 50
医学統計アドバンスコース第2回⽬ 試験デザインでの留意点 閾値(帰無仮説)には根拠が必要 HERBIS‐1では，ToGA試験(Y‐J Bang, et al. The Lancet, 28, 687 ‐697, 2010.
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