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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. *$)& 3
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  2. *$)&ͱ͸Կ͔ʁ
    2
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  12. ࣏ྍํ਑ετϥςδʔᶄ
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  21. ྫɿ%.͕ͳ͍ංຬ੒ਓʹ͓͚ΔηϚάϧνυܧଓ౤༩ͷମॏҡ࣋ޮՌᶆ
    21
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    ໨తɺ&TUJNBOEɺղੳํ๏·ͰҰཡ

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  22. ྫɿ%.͕ͳ͍ංຬ੒ਓʹ͓͚ΔηϚάϧνυܧଓ౤༩ͷମॏҡ࣋ޮՌᶇ
    22
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    શ෦ॻ͚ΔΘ͚͸ͳ͍ɺαϓϦʹ·Θ͢

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  23. ྫɿ%.͕ͳ͍ංຬ੒ਓʹ͓͚ΔηϚάϧνυܧଓ౤༩ͷମॏҡ࣋ޮՌᶈ
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    ਤʹ΋&TUJNBOEΛ൓ө

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  24. ྫɿத౳঱Ҏ্ͷ$01%ʹର͢Δࡎซ༻ٵೖྍ๏ͷ༻ྔޮՌᶃ
    24
    w ຫੑด࠹ੑഏ࣬ױʢ$01%ʣʹର͢ΔࡎʹΑΔݻఆ༻ྔϨδϝϯ͸༻ྔͰ͸ݕ౼͞Ε͍ͯͳ͍
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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

    ֤Ξϓϩʔν͸ɺҟͳΔʮFTUJNBOEʯʹΑͬͯࣔ
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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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    ม਺ ධՁ߲໨
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    ɺ͜͜Ͱఆٛͯ͠΋ྑ͍ɻ

    View full-size slide

  29. 45&1ͷ&TUJNBOEΛߟ͑Δ
    29
    ໨త ౶೘ප͕ͳ͍աମॏ·ͨ͸ංຬͷ੒ਓʹ͓͍ͯɺηϚάϧνυൽԼ஫NHͷܧଓ౤༩͸ମॏݮগͷҡ࣋ʹͲͷΑ͏ͳޮՌΛ༩͑Δ͔ʁ
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    ͷࢀՃऀ
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    ˠதؒࣄ৅ʹؔΘΒͳ͍࣏ྍͷޮՌʹؔ৺͕͋Δཧ༝

    ᶄ࣏ྍ୤མɾதࢭɾϨεΩϡʔ Ծ૝ετϥςδʔ


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

    View full-size slide

  30. &TUJNBOEΛҙࣝͨ͠ݚڀܭը
    30
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    View full-size slide

  31. ݚڀܭըॻ΁ͷ&TUJNBOEͷهࡌᶃ
    31
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  32. ݚڀܭըॻ΁ͷ&TUJNBOEͷهࡌᶄ
    32

    View full-size slide

  33. ݚڀܭըॻɿ%.͕ͳ͍ංຬ੒ਓʹ͓͚ΔηϚάϧνυܧଓ౤༩ͷମॏҡ࣋ޮՌ
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  34. ݚڀܭըॻɿத౳঱Ҏ্ͷ$01%ʹର͢Δࡎซ༻ٵೖྍ๏ͷ༻ྔޮՌ
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  35. &TUJNBOEΛܾΊΔͨΊͷڞಉ࡞ۀ
    35
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  36. ֶश͢ΔͨΊͷಓඪ
    36
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