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Factors Affecting Regulatory Decisions: Analysis of the Causes of Differences in Drug Indications between Countries

Research Project

Project/Area Number 21K10329
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Review Section Basic Section 58010:Medical management and medical sociology-related
Research InstitutionKagawa University

Principal Investigator

Ikeda Masayuki  香川大学, 医学部, 客員研究員 (10242215)

Co-Investigator(Kenkyū-buntansha) 嶋澤 るみ子  東海大学, 医学部, 教授 (00411083)
Project Period (FY) 2021-04-01 – 2024-03-31
Project Status Completed (Fiscal Year 2023)
Budget Amount *help
¥4,290,000 (Direct Cost: ¥3,300,000、Indirect Cost: ¥990,000)
Fiscal Year 2023: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2022: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2021: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Keywordsレギュラトリーサイエンス / 承認審査 / 国際比較研究 / 効能効果 / 医薬品評価学 / レギュラトリー・サイエンス / 医薬品情報 / 生活習慣病 / 人種差 / 医師主導治験 / モニタリング / ワクチン / 新型コロナウイルス感染症 / 国際比較
Outline of Research at the Start

多くの医薬品開発は国際共同治験として行われるが、必ずしも世界各国で同じ医薬品が同様に使用できるようになるわけではない。一見同一疾患を対象とした同一効能と認識されながら、効果判定のエンドポイントや疾患範囲の設定が異なる質的な効能の差異が生じることがある。本研究では、各国間でのこの質的な効能差に着目し、この質的効能差が認められる生活習慣病治療薬を主な対象として質的効能差を生む要因、つまり臨床的エビデンスに対する評価の差を検討する。この検討により、医薬品の効能決定をモデルとして、医薬品・医療政策の各国での判断が、どのような科学的、社会的要因に影響を受け決定されているのか明らかにする。

Outline of Final Research Achievements

In the case of drugs for lifestyle-related diseases, for which there are large epidemiological differences among countries, qualitative differences in indication may occur among countries, where the endpoints for indication determination and the range of diseases differ, even though they are recognized as the same indication for the same disease at first glance. In this study, we focus on this qualitative difference in indication among countries, and examine the factors that cause the qualitative difference in indication, i.e., the difference in the evaluation of clinical evidence, mainly for drugs for lifestyle-related diseases. The purpose of this study was to clarify the scientific and social factors that influence the decisions on pharmaceutical and medical policies in each country, using the indication of drugs as a model.

Academic Significance and Societal Importance of the Research Achievements

一見同一疾患を対象とした同一効能と認識されながら、効果判定のエンドポイントや疾患範囲の設定が異なる質的な効能の差異が,承認審査の結果生じることがある。本研究では、各国間でのこの質的な効能差に着目し、この質的効能差が認められる生活習慣病治療薬を主な対象として質的効能差を生む要因、つまり臨床的エビデンスに対する評価の差、を検討する。この検討により、医薬品の効能決定をモデルとして、医薬品・医療政策の各国での判断が、どのような科学的、社会的要因に影響を受け決定されているのかを明らかにした点にある。

Report

(4 results)
  • 2023 Annual Research Report   Final Research Report ( PDF )
  • 2022 Research-status Report
  • 2021 Research-status Report
  • Research Products

    (4 results)

All 2023 2022 2021

All Journal Article (4 results) (of which Peer Reviewed: 4 results,  Open Access: 2 results)

  • [Journal Article] Comparison of the Quality of Phase Ⅲ Non-commercial Clinical Trials in Japan, the United States, and the United Kingdom before the Implementation of the New Japanese Clinical Trials Act2023

    • Author(s)
      Yamauchi Y, Miwa Y, Ikeda M, Ueda S
    • Journal Title

      Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics

      Volume: 54 Issue: 3 Pages: 95-101

    • DOI

      10.3999/jscpt.54.3_95

    • ISSN
      0388-1601, 1882-8272
    • Year and Date
      2023-05-31
    • Related Report
      2023 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Errors Identified by Early, Risk-adapted, Triggered On-site Monitoring in Physician-initiated Clinical Trials not for Regulatory Approval in Cardiovascular Diseases2023

    • Author(s)
      Ikehara Y, Morimoto T, Ikeda M, Node K, Ueda S
    • Journal Title

      Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics

      Volume: 54 Issue: 1 Pages: 9-16

    • DOI

      10.3999/jscpt.54.1_9

    • ISSN
      0388-1601, 1882-8272
    • Year and Date
      2023-01-31
    • Related Report
      2023 Annual Research Report 2022 Research-status Report
    • Peer Reviewed
  • [Journal Article] Women with type 2 diabetes and coronary artery disease have a higher risk of heart failure than men, with a significant gender interaction between heart failure risk and risk factor management: a retrospective registry study2022

    • Author(s)
      Fujita Y, Morimoto T, Tokushige A, Ikeda M, Shimabukuro M, Node K, Ueda S
    • Journal Title

      BMJ Open Diabetes Res Care

      Volume: 10 Issue: 2 Pages: e002707-e002707

    • DOI

      10.1136/bmjdrc-2021-002707

    • Related Report
      2022 Research-status Report
    • Peer Reviewed / Open Access
  • [Journal Article] Potential adverse events in Japanese women who received tozinameran (BNT162b2, Pfizer-BioNTech)2021

    • Author(s)
      Shimazawa R, Ikeda M.
    • Journal Title

      Journal of Pharmaceutical Policy and Practice

      Volume: 14 Issue: 1 Pages: 46-46

    • DOI

      10.1186/s40545-021-00326-7

    • Related Report
      2021 Research-status Report
    • Peer Reviewed / Open Access

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Published: 2021-04-28   Modified: 2025-01-30  

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