English  |  正體中文  |  简体中文  |  全文笔数/总笔数 : 60984/93521 (65%)
造访人次 : 1570953      在线人数 : 155
RC Version 7.0 © Powered By DSPACE, MIT. Enhanced by NTU Library & TKU Library IR team.
搜寻范围 查询小技巧:
  • 您可在西文检索词汇前后加上"双引号",以获取较精准的检索结果
  • 若欲以作者姓名搜寻,建议至进阶搜寻限定作者字段,可获得较完整数据
  • 进阶搜寻

    jsp.display-item.identifier=請使用永久網址來引用或連結此文件: https://tkuir.lib.tku.edu.tw/dspace/handle/987654321/122705

    题名: Use of interval estimations in design and evaluation of multiregional clinical trials with continuous outcomes
    作者: Chiang, Chieh;Hsiao, Chin-Fu
    关键词: Multiregional clinical trial;interval estimation;sample size determination;Behrens–Fisher problem;consistency
    日期: 2018-01-22
    上传时间: 2022-05-09 12:10:44 (UTC+8)
    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.
    關聯: Statistical methods in medical research 28(7), p.2179-2195
    DOI: 10.1177/0962280217751277
    显示于类别:[數學學系暨研究所] 期刊論文


    档案 描述 大小格式浏览次数



    DSpace Software Copyright © 2002-2004  MIT &  Hewlett-Packard  /   Enhanced by   NTU Library & TKU Library IR teams. Copyright ©   - 回馈