國家衛生研究院 NHRI:Item 3990099045/10987
English  |  正體中文  |  简体中文  |  全文筆數/總筆數 : 12145/12927 (94%)
造訪人次 : 925007      線上人數 : 938
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/3990099045/10987


    題名: Use of interval estimations in design and evaluation of multiregional clinical trials with continuous outcomes
    作者: Chiang, C;Hsiao, CF
    貢獻者: Institute of Population Health Sciences
    摘要: Multiregional clinical trials have been accepted in recent years as a useful means of accelerating the development of new drugs and abridging their approval time. The statistical properties of multiregional clinical trials are being widely discussed. In practice, variance of a continuous response may be different from region to region, but it leads to the assessment of the efficacy response falling into a Behrens-Fisher problem-there is no exact testing or interval estimator for mean difference with unequal variances. As a solution, this study applies interval estimations of the efficacy response based on Howe's, Cochran-Cox's, and Satterthwaite's approximations, which have been shown to have well-controlled type I error rates. However, the traditional sample size determination cannot be applied to the interval estimators. The sample size determination to achieve a desired power based on these interval estimators is then presented. Moreover, the consistency criteria suggested by the Japanese Ministry of Health, Labour and Welfare guidance to decide whether the overall results from the multiregional clinical trial obtained via the proposed interval estimation were also applied. A real example is used to illustrate the proposed method. The results of simulation studies indicate that the proposed method can correctly determine the required sample size and evaluate the assurance probability of the consistency criteria.
    日期: 2019-07
    關聯: Statistical Methods in Medical Research. 2019 Jul;28(7):2179-2195.
    Link to: http://dx.doi.org/10.1177/0962280217751277
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0962-2802&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000474234600016
    Cited Times(Scopus): https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85043711302
    顯示於類別:[蕭金福] 期刊論文

    文件中的檔案:

    檔案 描述 大小格式瀏覽次數
    PUB29355082.pdf321KbAdobe PDF337檢視/開啟


    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