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ICH E9 (R1) 臨床試験のための統計的原則〜中間事象に対するストラテジー

Shuntaro Sato
December 18, 2022

ICH E9 (R1) 臨床試験のための統計的原則〜中間事象に対するストラテジー

ICH E9は、1998年に通知された臨床試験のための統計的原則です。その補遺であるE9(R1)は、臨床試験の目的とそれを解決するためのデザインから解析方法までを筋道立てて考えるフレームワークを提供します。治験に関わる者には認知されつつある考え方ですが、アカデミアでの普及は今ひとつです。しかし、その重要性や有用性はアカデミアでおこなう臨床試験にもあてはめることができます。
このスライドでは、E9(R1)の中の「中間事象に対応するためのストラテジー:A.3.2〜A.4」についてまとめました。

Shuntaro Sato

December 18, 2022
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  1. *$)& 3
    ྟচࢼݧͷͨΊͷ౷ܭతݪଇɹิҨͷ֓ཁɾࣄྫ

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    View Slide

  2. *$)&ͱ͸Կ͔ʁ
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  5. தؒࣄ৅ʹରԠ͢ΔͨΊͷετϥςδʔ
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  10. $2͔Β&TUJNBOEετϥςδʔ΁
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  12. ࣏ྍํ਑ετϥςδʔᶄ
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  21. ྫɿ%.͕ͳ͍ංຬ੒ਓʹ͓͚ΔηϚάϧνυܧଓ౤༩ͷମॏҡ࣋ޮՌᶆ
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  22. ྫɿ%.͕ͳ͍ංຬ੒ਓʹ͓͚ΔηϚάϧνυܧଓ౤༩ͷମॏҡ࣋ޮՌᶇ
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  23. ྫɿ%.͕ͳ͍ංຬ੒ਓʹ͓͚ΔηϚάϧνυܧଓ౤༩ͷମॏҡ࣋ޮՌᶈ
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  24. ྫɿத౳঱Ҏ্ͷ$01%ʹର͢Δࡎซ༻ٵೖྍ๏ͷ༻ྔޮՌᶃ
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    w ओཁධՁ߲໨ɿ$01%૿ѱͷ೥ؒൃੜ཰
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  25. ྫɿத౳঱Ҏ্ͷ$01%ʹର͢Δࡎซ༻ٵೖྍ๏ͷ༻ྔޮՌᶄ
    25
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    ͳ࿮૊ΈΛ࢖༻ͨ͠ɻ

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  26. ྫɿத౳঱Ҏ্ͷ$01%ʹର͢Δࡎซ༻ٵೖྍ๏ͷ༻ྔޮՌᶅ
    26
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  27. ྫɿத౳঱Ҏ্ͷ$01%ʹର͢Δࡎซ༻ٵೖྍ๏ͷ༻ྔޮՌᶆ
    27
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  28. &TUJNBOEΛߟ͑ΔςϯϓϨʔτ
    28
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    View Slide

  29. 45&1ͷ&TUJNBOEΛߟ͑Δ
    29
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    ᶄ࣏ྍ୤མɾதࢭɾϨεΩϡʔ Ծ૝ετϥςδʔ


    ˠதؒࣄ৅͕ͳ͘ɺ࣏ྍΛܧଓͨ͠ͱԾఆͨ͠ޮՌʹؔ৺͕͋Δཧ༝
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    ऀ͝ͱʹωετɻແߏ଄ͷڞ෼ࢄߦྻΛར༻ɻ

    View Slide

  30. &TUJNBOEΛҙࣝͨ͠ݚڀܭը
    30
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  31. ݚڀܭըॻ΁ͷ&TUJNBOEͷهࡌᶃ
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  32. ݚڀܭըॻ΁ͷ&TUJNBOEͷهࡌᶄ
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  33. ݚڀܭըॻɿ%.͕ͳ͍ංຬ੒ਓʹ͓͚ΔηϚάϧνυܧଓ౤༩ͷମॏҡ࣋ޮՌ
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  34. ݚڀܭըॻɿத౳঱Ҏ্ͷ$01%ʹର͢Δࡎซ༻ٵೖྍ๏ͷ༻ྔޮՌ
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  35. &TUJNBOEΛܾΊΔͨΊͷڞಉ࡞ۀ
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  36. ֶश͢ΔͨΊͷಓඪ
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