• Search Research Projects
  • Search Researchers
  • How to Use
  1. Back to previous page

Study on the factor influencing oncologic drugs approval review time between Japan and US.

Research Project

Project/Area Number 26350560
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Medical engineering assessment
Research InstitutionThe University of Tokyo

Principal Investigator

Nagamura Fumitaka  東京大学, 医科学研究所, 教授 (90282491)

Project Period (FY) 2014-04-01 – 2017-03-31
Project Status Completed (Fiscal Year 2016)
Budget Amount *help
¥3,250,000 (Direct Cost: ¥2,500,000、Indirect Cost: ¥750,000)
Fiscal Year 2016: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2015: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Fiscal Year 2014: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Keywords抗がん剤 / 医薬品開発 / 日米 / 承認 / レギュラトリーサイエンス / 承認審査 / 開発環境
Outline of Final Research Achievements

Various factors have reported as the cause of oncologic drug lag. Review time of Pharmaceuticals and Medical Devices Agency in Japan has become almost as same as that of U.S. Food and Drug Administration. However, drug lag is still shown. To study on the cause of drug lag between Japan and U.S., 41 oncologic drugs approved between 2001 and 2014 in both countries were analyzed. Drug lag of drugs approved between 2001 and 2010 is 57 months (mean), and that after 2011 was 9 months. Factors including guidance for treatment were analyzed, and most influenced factor is the kind of pivotal studies. In seven drugs out of eight drugs, pivotal studies were conducted as multinational studies. To achieve earlier approval, participation into multinational clinical trials is considered the most important factor.

Report

(4 results)
  • 2016 Annual Research Report   Final Research Report ( PDF )
  • 2015 Research-status Report
  • 2014 Research-status Report

Research Products

(20 results)

All 2017 2016 2015 2014

All Journal Article (5 results) (of which Peer Reviewed: 3 results,  Open Access: 1 results) Presentation (10 results) Book (5 results)

  • [Journal Article] he effects of bolus supplementation of branched-chain amino acids on skeletal muscle mass, strength, and function in patients with rheumatic disorders during glucocorticoid treatment.2016

    • Author(s)
      Yoshikawa N, Shimizu N, Uehara M, Oda A, Matsumiya R, Matsubara E, Kobayashi H, Hosono O, Kuribara-Souta A, Baba H, Nagamura F, Kiryu S, Tanaka H.
    • Journal Title

      Mod Rheumatol.

      Volume: 28 Pages: 1-10

    • Related Report
      2016 Annual Research Report
    • Peer Reviewed
  • [Journal Article] The Importance of Recruiting a Diverse Population for Stem Cell Clinical Trials.2016

    • Author(s)
      Nagamura F.
    • Journal Title

      Current Stem Cell Reports.

      Volume: 2 Pages: 321-327

    • Related Report
      2016 Annual Research Report
    • Peer Reviewed
  • [Journal Article] アカデミアにおけるシーズ開発と研究者のための連携2015

    • Author(s)
      長村文孝
    • Journal Title

      日本薬理学雑誌

      Volume: 145 Pages: 211-215

    • Related Report
      2015 Research-status Report
  • [Journal Article] Effect of graft sources on allogeneic hematopoietic stem cell transplantation outcome in adults with chronic myeloid leukemia in the era of tyrosine kinase inhibitors: a Japanese Society of Hematopoietic Cell Transplantation retrospective analysis.2014

    • Author(s)
      Ohashi K, Nagamura-Inoue T, Nagamura F, Tojo A, Miyamura K, Mori T, Kurokawa M, Taniguchi S, Ishikawa J, Morishima Y, Atsuta Y, Sakamaki H.
    • Journal Title

      Int J Hematol

      Volume: 100 Pages: 296-306

    • DOI

      10.1007/s12185-014-1632-9

    • Related Report
      2014 Research-status Report
    • Peer Reviewed / Open Access
  • [Journal Article] トランスレーショナルリサーチの重要性2014

    • Author(s)
      長村文孝
    • Journal Title

      病院

      Volume: 73(7) Pages: 540-544

    • Related Report
      2014 Research-status Report
  • [Presentation] 多変量解析の不適切利用是正に向けた医学論文サーベイランス2017

    • Author(s)
      野島正寛, 徳永睦, 長村文孝
    • Organizer
      日本疫学会学術総会
    • Place of Presentation
      甲府市
    • Related Report
      2016 Annual Research Report
  • [Presentation] 再生医療臨床研究における研究者向けインフォームド・コンセント教育用DVD開発の試み2017

    • Author(s)
      楠瀬まゆみ、長村文孝、中澤栄輔、田代志門、武藤香織
    • Organizer
      日本再生医療学会総会
    • Place of Presentation
      仙台市
    • Related Report
      2016 Annual Research Report
  • [Presentation] 文書処理手順の見直しによる治験開始手続きに要する日数の短縮2017

    • Author(s)
      岡田美和子、米富さつき、武藤美和子、金沢敬子、長村文孝
    • Organizer
      日本臨床試験学会
    • Place of Presentation
      大阪市
    • Related Report
      2016 Annual Research Report
  • [Presentation] 再生医療とバンキング(臍帯由来間葉系細胞)~アカデミアにおける開発2016

    • Author(s)
      長村文孝
    • Organizer
      細胞再生医療研究会
    • Place of Presentation
      神戸市
    • Related Report
      2016 Annual Research Report
  • [Presentation] AROを担う人材教育2016

    • Author(s)
      長村文孝
    • Organizer
      ARO協議会総会
    • Place of Presentation
      豊中市
    • Related Report
      2016 Annual Research Report
  • [Presentation] アカデミア発治験薬を用いた医師主導治験(第I相)のTRC業務における現状と課題2016

    • Author(s)
      大和田 理代、河野美那子、栁真志帆、堀部恵梨佳、蓑手沙織、長村文孝
    • Organizer
      CRCの在り方を考える会議
    • Place of Presentation
      さいたま市
    • Related Report
      2016 Annual Research Report
  • [Presentation] E-sourceのカスタマイズにおけるCRCのかかわり  ~医師主導治験への導入事例~2015

    • Author(s)
      栁 真志帆、河野 美那子、蓑手 沙織、高野 淳、醍醐 弥太郎、長村 文孝
    • Organizer
      日本臨床薬理学会
    • Place of Presentation
      東京
    • Year and Date
      2015-12-09
    • Related Report
      2015 Research-status Report
  • [Presentation] 非B非C肝癌における大規模マイクロRNAクラスターの低メチル化とその意義2015

    • Author(s)
      野島正寛、松井剛志、飯尾悦子、田守昭博、久保正二、調憲、木村光一、島田光生、宇都宮徹、近藤泰輝、落合孝宏、長村文孝、田中靖人
    • Organizer
      日本癌学会
    • Place of Presentation
      名古屋
    • Year and Date
      2015-10-08
    • Related Report
      2015 Research-status Report
  • [Presentation] トランスレーショナルリサーチ及び医師主導治験実施におけるTRC会議の有用性2015

    • Author(s)
      野美那子、大和田理代、堀部恵梨佳、蓑手 沙織、栁真志帆、長村文孝
    • Organizer
      CRCと臨床試験のあり方を考える会議
    • Place of Presentation
      神戸
    • Year and Date
      2015-09-12
    • Related Report
      2015 Research-status Report
  • [Presentation] Nursing Education Program on Translational Research as a Master’s Course.2014

    • Author(s)
      Noriko Fujiwara, Fumitaka Nagamura, Kazufumi Matsumoto, Naohide Yamashita, Yukie Takemura, Kiyoko Kamibeppu.
    • Organizer
      International Association of Clinical Research Nurses.
    • Place of Presentation
      Revere Hotel - Boston, Massachusetts USA
    • Year and Date
      2014-11-05 – 2014-11-07
    • Related Report
      2014 Research-status Report
  • [Book] 次世代がん治療研究最前線2017

    • Author(s)
      長村文孝
    • Total Pages
      300
    • Publisher
      株式会社エヌ・ティー・エス
    • Related Report
      2016 Annual Research Report
  • [Book] 実験医学:ウイルス療法のガイドライン・ガイダンスについて2016

    • Author(s)
      長村文孝
    • Total Pages
      1
    • Publisher
      羊土社
    • Related Report
      2016 Annual Research Report
  • [Book] 実験医学:ウイルス療法のガイドライン・ガイダンスについて2016

    • Author(s)
      長村 文孝
    • Total Pages
      1
    • Publisher
      羊土社
    • Related Report
      2015 Research-status Report
  • [Book] 医薬品/医療機器の承認申請書の上手な書き方・まとめ方2014

    • Author(s)
      長村文孝、他
    • Total Pages
      491
    • Publisher
      技術情報協会
    • Related Report
      2014 Research-status Report
  • [Book] がん患者のこころに寄り添うためにサイコオンコロジーの基礎と実践2014

    • Author(s)
      長村文孝、他(編集 大木桃代)
    • Total Pages
      232
    • Publisher
      真興交易㈱医書出版部
    • Related Report
      2014 Research-status Report

URL: 

Published: 2014-04-04   Modified: 2018-03-22  

Information User Guide FAQ News Terms of Use Attribution of KAKENHI

Powered by NII kakenhi