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Re-evaluation of evidence reflecting patient's value with individual patient based meta-analysis

Research Project

Project/Area Number 21H03401
Research Category

Grant-in-Aid for Scientific Research (B)

Allocation TypeSingle-year Grants
Section一般
Review Section Basic Section 60030:Statistical science-related
Research InstitutionThe University of Tokyo

Principal Investigator

OBA Koji  東京大学, 大学院情報学環・学際情報学府, 准教授 (30422926)

Co-Investigator(Kenkyū-buntansha) 川原 拓也  東京大学, 医学部附属病院, 助教 (10792450)
坂巻 顕太郎  順天堂大学, 健康データサイエンス学部, 准教授 (30644819)
Project Period (FY) 2021-04-01 – 2024-03-31
Project Status Completed (Fiscal Year 2023)
Budget Amount *help
¥13,910,000 (Direct Cost: ¥10,700,000、Indirect Cost: ¥3,210,000)
Fiscal Year 2023: ¥4,550,000 (Direct Cost: ¥3,500,000、Indirect Cost: ¥1,050,000)
Fiscal Year 2022: ¥4,680,000 (Direct Cost: ¥3,600,000、Indirect Cost: ¥1,080,000)
Fiscal Year 2021: ¥4,680,000 (Direct Cost: ¥3,600,000、Indirect Cost: ¥1,080,000)
Keywordsメタアナリシス / リスク・ベネフィット評価 / 個別化医療 / 臨床試験 / 因果推論
Outline of Research at the Start

本研究課題では、過去に実施された臨床試験の個人データ(Individual Patient Data: IPD)メタアナリシスの枠組みで、リスク・ベネフィットに関連する複数のアウトカムに対して臨床的意義やエビデンスを利用する患者の選好を反映させた順位付け(Prioritized
Outcomes: PO) に基づいた再評価を行うことにより、個別の患者の価値に基づいた治療選択を可能にする新しいエビデンスの利用方法を提案する。これまでの集団のデータに基づいて決められてきた治療方法の評価から、個人の価値観に基づいて治療の優先順位を再検討できるようなShared Decision Makingの実践を目指す。

Outline of Final Research Achievements

In this study, we aimed to propose a new method of utilizing evidence that allows for treatment selection reflecting individual patient values by using Generalized Pairwise Comparison (GPC), a method proposed for evaluating risk-benefit in clinical trials. We evaluated the performance of GPC based on literature reviews and theoretical considerations, and conducted a real data analysis comparing S-1 and 5FU using data from the GASTRIC study, an international collaborative IPD (Individual Patient/Participant Data) meta-analysis of advanced and recurrent gastric cancer. The results indicated that S-1 is a superior treatment to 5FU, demonstrating the usefulness of GPC-based risk-benefit evaluation.

Academic Significance and Societal Importance of the Research Achievements

ランダム化比較試験に対する既存の個人データがデータベース化されることにより、GPCを用いたエビデンスの再評価を行うことによって、エビデンスを利用する患者の優先順位や選考を反映させた評価が可能となることを示した。これにより、利用者の観点に立った新しいエビデンスの利用方法を示すことにつながった。

Report

(3 results)
  • 2023 Final Research Report ( PDF )
  • 2022 Annual Research Report
  • 2021 Annual Research Report
  • Research Products

    (16 results)

All 2023 2022 2021 Other

All Int'l Joint Research (4 results) Journal Article (5 results) (of which Int'l Joint Research: 2 results,  Peer Reviewed: 5 results,  Open Access: 5 results) Presentation (5 results) (of which Int'l Joint Research: 1 results,  Invited: 1 results) Book (1 results) Remarks (1 results)

  • [Int'l Joint Research] Institute Curie(フランス)

    • Related Report
      2022 Annual Research Report
  • [Int'l Joint Research] Hasselt University(ベルギー)

    • Related Report
      2022 Annual Research Report
  • [Int'l Joint Research] Institute Curie(フランス)

    • Related Report
      2021 Annual Research Report
  • [Int'l Joint Research] Hasselt University(ベルギー)

    • Related Report
      2021 Annual Research Report
  • [Journal Article] Generalized Pairwise Comparisons for Survival Analysis2023

    • Author(s)
      福田 武蔵、坂巻 顕太郎、大庭 幸治
    • Journal Title

      Journal of the Japan Statistical Society, Japanese Issue

      Volume: 52 Issue: 2 Pages: 319-354

    • DOI

      10.11329/jjssj.52.319

    • ISSN
      0389-5602, 2189-1478
    • Year and Date
      2023-03-01
    • Related Report
      2022 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Impact of correlations between prioritized outcomes on?the?net benefit and its estimate by generalized pairwise comparisons2023

    • Author(s)
      Fuyama Kanako、Ogawa Mitsunori、Mizusawa Junki、Kanemitsu Yukihide、Fujita Shin、Kawahara Takuya、Sakamaki Kentaro、Oba Koji
    • Journal Title

      Statistics in Medicine

      Volume: 42 Issue: 10 Pages: 1606-1624

    • DOI

      10.1002/sim.9690

    • Related Report
      2022 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] Statistical methods and graphical displays of quality of life with survival outcomes in oncology clinical trials for supporting the estimand framework2022

    • Author(s)
      Sakamaki Kentaro、Kawahara Takuya
    • Journal Title

      BMC Medical Research Methodology

      Volume: 22 Issue: 1 Pages: 1-11

    • DOI

      10.1186/s12874-022-01735-1

    • Related Report
      2022 Annual Research Report
    • Peer Reviewed / Open Access / Int'l Joint Research
  • [Journal Article] Impact of follow-up on generalized pairwise comparisons for estimating the irinotecan benefit in advanced/metastatic gastric cancer2021

    • Author(s)
      Chamseddine Ali N.、Oba Koji、Buyse Marc、Boku Narikazu、Bouch? Olivier、Satar Tuvana、Auperin Anne、Paoletti Xavier
    • Journal Title

      Contemporary Clinical Trials

      Volume: 105 Pages: 106400-106400

    • DOI

      10.1016/j.cct.2021.106400

    • Related Report
      2021 Annual Research Report
    • Peer Reviewed / Open Access / Int'l Joint Research
  • [Journal Article] Misleading Reporting (Spin) in Noninferiority Randomized Clinical Trials in Oncology With Statistically Not Significant Results2021

    • Author(s)
      Ito Chiyo、Hashimoto Atsushi、Uemura Kohei、Oba Koji
    • Journal Title

      JAMA Network Open

      Volume: 4 Issue: 12 Pages: e2135765-e2135765

    • DOI

      10.1001/jamanetworkopen.2021.35765

    • Related Report
      2021 Annual Research Report
    • Peer Reviewed / Open Access
  • [Presentation] 一般化ペアワイズ比較を用いた生存時間データの解析2022

    • Author(s)
      福田 武蔵、坂巻 顕太郎、大庭 幸治.
    • Organizer
      2022年度統計関連学会連合大会
    • Related Report
      2022 Annual Research Report
  • [Presentation] Impact of correlations between prioritized outcomes on the net benefit and its estimate by generalized pairwise comparisons2022

    • Author(s)
      Fuyama K、Ogawa M、Mizusawa J、Oba K
    • Organizer
      WNAR/IMS
    • Related Report
      2022 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Global Advanced/Adjuvant Stomach Tumor Research International Collaboration through Individual Patient based Data Meta-analysis: GASTRIC project2022

    • Author(s)
      Oba K
    • Organizer
      日本臨床腫瘍学会
    • Related Report
      2021 Annual Research Report
  • [Presentation] メタアナリシス、ネットワークメタアナリシスの見方・読み方2021

    • Author(s)
      大庭幸治
    • Organizer
      日本循環器学会関東甲信越地方会
    • Related Report
      2021 Annual Research Report
    • Invited
  • [Presentation] 比例ハザード性が成立しない生存時間データにおけるペアワイズ比較2021

    • Author(s)
      坂巻 顕太郎
    • Organizer
      SASユーザー総会2021
    • Related Report
      2021 Annual Research Report
  • [Book] 臨床試験の事典2023

    • Author(s)
      丹後 俊郎、松井 茂之
    • Total Pages
      608
    • Publisher
      朝倉書店
    • ISBN
      9784254322644
    • Related Report
      2022 Annual Research Report
  • [Remarks] THE GASTRIC

    • URL

      https://gastricproject.org/

    • Related Report
      2022 Annual Research Report 2021 Annual Research Report

URL: 

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

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