國家衛生研究院 NHRI:Item 3990099045/11452
English  |  正體中文  |  简体中文  |  全文筆數/總筆數 : 12145/12927 (94%)
造訪人次 : 924366      線上人數 : 830
RC Version 6.0 © Powered By DSPACE, MIT. Enhanced by NTU Library IR team.
搜尋範圍 查詢小技巧：
  • 您可在西文檢索詞彙前後加上"雙引號"，以獲取較精準的檢索結果
  • 若欲以作者姓名搜尋，建議至進階搜尋限定作者欄位，可獲得較完整資料
    •  進階搜尋
    主頁 ‧ 登入 ‧ 上傳 ‧ 說明 ‧ 關於NHRI ‧ 管理 到手機版


    請使用永久網址來引用或連結此文件: http://ir.nhri.org.tw/handle/3990099045/11452


    題名: The discrete random-effects model-assessing benefit and consistency of treatment effect
    作者: Tsou, HH;Lan, KKG;Liu, JT;Hsiao, CF
    貢獻者: Institute of Population Health Sciences
    摘要: The traditionally uniform treatment effect assumption may be inappropriate in an multiregional clinical trial (MRCT) because of the impact on the drug effect due to regional differences. Lan and and Pinheiro (2012) proposed a discrete random effects model (DREM) to account the treatment effects heterogeneity among regions. However, the benefit of the overall drug effect and the consistency of the treatment effect in each region are two major issues in MRCTs. In this article, the power of benefit is derived under DREM and the overall sample size determination in an MRCT. Comparison of DREM and traditional continuous random effects model (CREM) is also illustrated here. In order to assess the treatment benefit and consistency simultaneously under DREM, we consider the concept of the Method 2 in “Basic Principles on Global Clinical Trials” guidance to construct the probability function of benefit and consistency. We also optimize the sample size allocation to reach maximum power for the benefit and consistency.
    日期: 2016-04-21
    關聯: Multiregional Clinical Trials for Simultaneous Global New Drug Development. 2016 Apr 21:245-258.
    Link to: https://www.taylorfrancis.com/books/e/9781498701488
    Cited Times(Scopus): https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85052574924
    顯示於類別:[蕭金福] 圖書
    [鄒小蕙] 圖書

    文件中的檔案:

    沒有與此文件相關的檔案.



    在NHRI中所有的資料項目都受到原著作權保護.

    TAIR相關文章

    DSpace Software Copyright © 2002-2004  MIT &  Hewlett-Packard  /   Enhanced by   NTU Library IR team Copyright ©   - 回饋