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A new clinical trial design considering the efficiency of multiple primary endpoints

Research Project

Project/Area Number 25870332
Research Category

Grant-in-Aid for Young Scientists (B)

Allocation TypeMulti-year Fund
Research Field Statistical science
Epidemiology and preventive medicine
Research InstitutionKyoto University

Principal Investigator

SOZU Takashi  京都大学, 医学研究科, 准教授 (80408723)

Project Period (FY) 2013-04-01 – 2015-03-31
Project Status Completed (Fiscal Year 2014)
Budget Amount *help
¥2,080,000 (Direct Cost: ¥1,600,000、Indirect Cost: ¥480,000)
Fiscal Year 2014: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2013: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Keywords医薬品開発 / 治験 / 主要評価変数 / エンドポイント / 費用効率 / 多重性 / サンプルサイズ / 群逐次デザイン
Outline of Final Research Achievements

We developed a new design for clinical trials comparing two treatments using multiple primary endpoints in which the number of necessary measurements is determined for each of the endpoints, taking into consideration both the cost and the individual power for each endpoint. We compared the efficiency of the proposed design with that of the conventional design using three variables: (1) the number of participants in the study, (2) the total number of measurements for all endpoints, and (3) the cost of enrolling the participants and obtaining the measurements for all endpoints. The conditions for the proposed design to be useful were found. We extended the proposed design to a group-sequential design.

Report

(3 results)
  • 2014 Annual Research Report   Final Research Report ( PDF )
  • 2013 Research-status Report
  • Research Products

    (11 results)

All 2015 2014 2013 Other

All Journal Article (6 results) (of which Peer Reviewed: 6 results,  Acknowledgement Compliant: 2 results,  Open Access: 1 results) Presentation (3 results) (of which Invited: 1 results) Book (1 results) Remarks (1 results)

  • [Journal Article] Reducing unnecessary measurements in clinical trials with multiple primary endpoints2015

    • Author(s)
      Sozu T, Sugimoto T, Hamasaki T
    • Journal Title

      Journal of Biopharmaceutical Statistics

      Volume: 掲載確定

    • Related Report
      2014 Annual Research Report
    • Peer Reviewed / Acknowledgement Compliant
  • [Journal Article] Sample size considerations in clinical trials when comparing two interventions using multiple co-primary binary relative risk contrasts2015

    • Author(s)
      Ando Y, Hamasaki T, Evans SR, Asakura K, Sugimoto T, Sozu T, Ohno Y
    • Journal Title

      Statistics in Biopharmaceutical Research

      Volume: 掲載確定

    • Related Report
      2014 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Group-sequential strategies in clinical trials with multiple co-primary outcomes2015

    • Author(s)
      Hamasaki H, Asakura K, Evans, SR, Sugimoto T, Sozu T
    • Journal Title

      Statistics in Biopharmaceutical Research

      Volume: 7 Issue: 1 Pages: 36-54

    • DOI

      10.1080/19466315.2014.1003090

    • NAID

      120005619770

    • Related Report
      2014 Annual Research Report
    • Peer Reviewed
  • [Journal Article] A new procedure of one-sided test in clinical trials with multiple endpoints2015

    • Author(s)
      Nakazuru Y, Sozu T, Hamada C, Yoshimura I
    • Journal Title

      Japanese Journal of Biometrics

      Volume: 35 Pages: 17-35

    • NAID

      130004840600

    • Related Report
      2014 Annual Research Report
    • Peer Reviewed / Acknowledgement Compliant
  • [Journal Article] Sample size determination in group-sequential clinical trials with two co-primary endpoints2014

    • Author(s)
      Asakura, K., Hamasaki, T., Sugimoto, T., Hayashi, K., Evans, S., Sozu T
    • Journal Title

      Statistics in Medicine

      Volume: (First published online) Issue: 17 Pages: 2897-2913

    • DOI

      10.1002/sim.6154

    • Related Report
      2014 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] 主要評価変数が複数ある臨床試験の統計的諸問題2013

    • Author(s)
      寒水孝司,杉本知之,濱崎俊光
    • Journal Title

      計量生物学

      Volume: 34 Pages: 35-52

    • NAID

      10031194714

    • Related Report
      2013 Research-status Report
    • Peer Reviewed
  • [Presentation] 臨床試験における多重性の諸問題2014

    • Author(s)
      寒水孝司
    • Organizer
      2014年計量生物セミナー
    • Place of Presentation
      キャンパスプラザ京都 (京都府京都市)
    • Year and Date
      2014-12-19
    • Related Report
      2014 Annual Research Report
  • [Presentation] 主要評価変数が複数ある臨床試験の統計的諸問題2014

    • Author(s)
      寒水孝司
    • Organizer
      バイオ統計センター公開セミナー
    • Place of Presentation
      久留米大学 (福岡県久留米市)
    • Year and Date
      2014-10-09
    • Related Report
      2014 Annual Research Report
    • Invited
  • [Presentation] A cost-effective clinical trial design with multiple primary endpoints2014

    • Author(s)
      Sozu T, Sugimoto T, Hamasaki T
    • Organizer
      XXVII International Biometric Conference
    • Place of Presentation
      Florence (Italy)
    • Year and Date
      2014-07-10 – 2014-07-11
    • Related Report
      2014 Annual Research Report
  • [Book] Sample Size Determination in Clinical Trials with Multiple Primary Endpoints2015

    • Author(s)
      Sozu T, Sugimoto T, Hamasaki T, Evans SR
    • Publisher
      Springer
    • Related Report
      2014 Annual Research Report
  • [Remarks]

    • URL

      http://www.kbs.med.kyoto-u.ac.jp/sozu/software.html

    • Related Report
      2014 Annual Research Report

URL: 

Published: 2014-07-25   Modified: 2019-07-29  

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