A study of evaluating issue of the drug development scientifically and predicting the adaptive development quantitatively.

• Project/Area Number: 22659108
• Research Category: Grant-in-Aid for Challenging Exploratory Research
• Allocation Type: Single-year Grants
• Research Field: Medical sociology
• Research Institution: Osaka University (2012); National Hospital Organization Osaka National Hospital Institute for Clinical Reserch (2010-2011)
• Principal Investigator: MAKIE Toshio 大阪大学, 医学部附属病院, 特任教授(常勤) (80435891)
• Co-Investigator(Kenkyū-buntansha): IMAI Masaki 名古屋市立大学, 医学(系)研究科(研究院), 講師 (30440936) ; KITATANI Kazuyuki 東北大学, 東北メディカル・メガバンク機構, 助教 (40539235) ; MORINAGA Osamu 長崎国際大学, 薬学部, 准教授 (60465771) ; NAKAMURA Tsuyoshi 中央大学, 理工学部, 客員教授 (80039586)
• Project Period (FY): 2010 – 2012
• Project Status: Completed (Fiscal Year 2012)
• Budget Amount: ¥2,500,000 (Direct Cost: ¥2,200,000、Indirect Cost: ¥300,000); Fiscal Year 2012: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000); Fiscal Year 2011: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000); Fiscal Year 2010: ¥1,200,000 (Direct Cost: ¥1,200,000)
• Keywords: 臨床試験(治験) / 創薬 / 薬剤疫学 / 規制科学 / 臨床試験登録サイト / International Clinical Trial Research Portal(ICTRP)site / Drug lag / 臨床研究 / 臨床試験（治験） / ICTRP / 臨床試験 / 臨床研究情報検索サイト / C型肝炎治療薬 / HIV感染症研究 / JAPIC / UMIN / 治験促進センター

Research Abstract

Information about a drug development is available at two sources, one is from the National Institution of Public Health and the other is the international clinical trial research platform managed by WHO. Finally all information of the clinical study is collected to the site managed by WHO. Almost all the information of Hepatitis type C was available from the portal site managed by WHO, whileonly a half of the information was available from the portal site of the domestic institution. We showed that the information of the drug development can be obtained more than two years earlier rather than waiting the publication of the study, using these sites.

Research Products

• [Journal Article] C 型慢性肝炎の治療薬開発を通してみた国内外の臨床試験検索サイトの活用方法の模索 (2012)
  • Author(s): 牧江 俊雄 黒田 祥平、中村 剛、森永 紀、今井 優樹、北谷 和之
  • Journal Title: 医薬品医療機器レギュラトリーサイエンス Volume: 43(5) Pages: 446-451
  • NAID: 40019323065
  • Peer Reviewed
• [Journal Article] C型慢性肝炎の治療薬開発を通してみた国内外の臨床試験検索サイトの活用方法の模索 (2012)
  • Author(s): 牧江 俊雄
  • Journal Title: 医薬品医療機器レギュラトリーサイエンス Volume: 43(5) Pages: 446-451
  • NAID: 40019323065
  • Peer Reviewed
• [Journal Article] 国内臨床試験の状況からみるC型慢性肝炎の治療の展望 (2012)
  • Author(s): 牧江俊雄, 中村剛, 今井優樹, 森永紀, 北谷和之
  • Journal Title: 医薬品医療機器レギュラトリーサイエンス Volume: 43 Pages: 446-451
  • Peer Reviewed
• [Presentation] (2011)
  • Author(s): 牧江 俊雄
  • Organizer: 第4回抗感染症薬開発フォーラム(感染症学会)
  • Place of Presentation: 東京
  • Year and Date: 2011-10-22
• [Presentation] 医薬品審査における医師の役割 (2011)
  • Author(s): 牧江俊雄
  • Organizer: 第4回抗感染症薬開発フォーラム(感染症学会)
  • Place of Presentation: 東京
  • Year and Date: 2011-10-22
• [Presentation] 抗HIV薬等の承認問題と今後の課題 (2010)
  • Author(s): 牧江俊雄
  • Organizer: 日本エイズ学会学術集会・総会
  • Place of Presentation: 東京
  • Year and Date: 2010-11-26