國家衛生研究院 NHRI:Item 3990099045/9577
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    題名: Assessing the consistency of the treatment effect under the discrete random effects model in multiregional clinical trials
    作者: Liu, JT;Tsou, HH;Gordon Lan, KK;Chen, CT;Lai, YH;Chang, WJ;Tzeng, CS;Hsiao, CF
    貢獻者: Division of Clinical Trial Statistics;Division of Biostatistics and Bioinformatics
    摘要: In recent years, developing pharmaceutical products via multiregional clinical trials (MRCTs) has become standard. Traditionally, an MRCT would assume that a treatment effect is uniform across regions. However, heterogeneity among regions may have impact upon the evaluation of a medicine's effect. In this study, we consider a random effects model using discrete distribution (DREM) to account for heterogeneous treatment effects across regions for the design and evaluation of MRCTs. We derive an power function for a treatment that is beneficial under DREM and illustrate determination of the overall sample size in an MRCT. We use the concept of consistency based on Method 2 of the Japanese Ministry of Health, Labour, and Welfare's guidance to evaluate the probability for treatment benefit and consistency under DREM. We further derive an optimal sample size allocation over regions to maximize the power for consistency. Moreover, we provide three algorithms for deriving sample size at the desired level of power for benefit and consistency. In practice, regional treatment effects are unknown. Thus, we provide some guidelines on the design of MRCTs with consistency when the regional treatment effect are assumed to fall into a specified interval. Numerical examples are given to illustrate applications of the proposed approach.
    日期: 2016-06
    關聯: Statistics in Medicine. 2016 Jun;35(14):2301-2314.
    Link to: http://dx.doi.org/10.1002/sim.6869
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0277-6715&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000378537100001
    Cited Times(Scopus): http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=84957604827
    顯示於類別:[蕭金福] 期刊論文
    [鄒小蕙] 期刊論文

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