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
Main Authors 蝦名, 潤哉, 長澤, 潤平, 狩野, 修, 平山, 剛久
Format Journal Article
LanguageJapanese
Published 日本神経治療学会 2025
Subjects
Online AccessGet full text
ISSN0916-8443
2189-7824
DOI10.15082/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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  fullname: 長澤, 潤平
  organization: 東邦大学医学部内科学講座脳神経内科学分野
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  fullname: 狩野, 修
  organization: 東邦大学医学部内科学講座脳神経内科学分野
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  fullname: 平山, 剛久
  organization: 東邦大学医学部内科学講座脳神経内科学分野
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Copyright 2025 日本神経治療学会
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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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StartPage 25
SubjectTerms amyotrophic lateral sclerosis
clinical trial
platform trial
rare disease
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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