新しい試験デザインを用いた開発 世界のALS臨床試験と今後の日本の展望
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Published in | 神経治療学 Vol. 42; no. 1; pp. 25 - 28 |
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Main Authors | , , , |
Format | Journal Article |
Language | Japanese |
Published |
日本神経治療学会
2025
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Subjects | |
Online Access | Get full text |
ISSN | 0916-8443 2189-7824 |
DOI | 10.15082/jsnt.42.1_25 |
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Author | 蝦名, 潤哉 平山, 剛久 狩野, 修 長澤, 潤平 |
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References | 4) 厚生科学審議会:医薬品医療機器制度部会 資料1–2 令和6年2月9日 3) Sugisawa T, Morioka H, Hirayama T et al : Multidisciplinary clinic contributes to the decreasing trend in the number of emergency hospitalizations for amyotrophic lateral sclerosis in Japan. J Clin Neurosci 107 : 133–137, 2023 2) Paganoni S, Berry JD, Quintana M et al : Adaptive Platform Trials to Transform Amyotrophic Lateral Sclerosis Therapy Development. Ann Neurol 91 : 165–175, 2022 6) https://www.ncc.go.jp/jp/ncch/masterkeyproject/outline/overview/master_key_project_overview.html 7) https://www.janima.org 1) Mitsumoto H, Brooks BR, Silani V : Clinical trials in amyotrophic lateral sclerosis : why so many negative trials and how can trials be improved? Lancet Neurol 13 : 1127–1138, 2014 5) Okuma HS, Yonemori K, Narita SN et al : MASTER KEY Project : Powering Clinical Development for Rare Cancers Through a Platform Trial. Clin Pharmacol Ther 108 : 596–605, 2020 |
References_xml | – reference: 6) https://www.ncc.go.jp/jp/ncch/masterkeyproject/outline/overview/master_key_project_overview.html – reference: 1) Mitsumoto H, Brooks BR, Silani V : Clinical trials in amyotrophic lateral sclerosis : why so many negative trials and how can trials be improved? Lancet Neurol 13 : 1127–1138, 2014 – reference: 4) 厚生科学審議会:医薬品医療機器制度部会 資料1–2 令和6年2月9日 – reference: 3) Sugisawa T, Morioka H, Hirayama T et al : Multidisciplinary clinic contributes to the decreasing trend in the number of emergency hospitalizations for amyotrophic lateral sclerosis in Japan. J Clin Neurosci 107 : 133–137, 2023 – reference: 5) Okuma HS, Yonemori K, Narita SN et al : MASTER KEY Project : Powering Clinical Development for Rare Cancers Through a Platform Trial. Clin Pharmacol Ther 108 : 596–605, 2020 – reference: 7) https://www.janima.org/ – reference: 2) Paganoni S, Berry JD, Quintana M et al : Adaptive Platform Trials to Transform Amyotrophic Lateral Sclerosis Therapy Development. Ann Neurol 91 : 165–175, 2022 |
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Title | 新しい試験デザインを用いた開発 世界のALS臨床試験と今後の日本の展望 |
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