國家衛生研究院 NHRI:Item 3990099045/7986
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    题名: Sample size estimation of multiregional clinical trials with heterogeneous variability across regions
    作者: Wu, YJ;Tan, TS;Chow, SC;Hsiao, CF
    贡献者: Division of Biostatistics and Bioinformatics;Division of Clinical Trial Statistics
    摘要: In recent years, global collaboration has become a conventional strategy for new drug development. To accelerate the development process and shorten approval time, the design of multiregional clinical trials (MRCTs) incorporates subjects from many countries around the world under the same protocol. After showing the overall efficacy of a drug in all global regions, one can also simultaneously evaluate the possibility of applying the overall trial results to all regions and subsequently support drug registration in each of them. Several statistical methods have been proposed for the design and evaluation of MRCTs. Most of these approaches, however, assume a common variability of the primary endpoint across regions. In practice, this assumption may not be true, due to differences across regions (e.g., differences in ethnic factors and/or medical culture/practice). In this article, we use a random-effect model for modeling heterogeneous variability across regions for the design and evaluation of MRCTs. We also address consideration on the determination of the number of subjects in a specific region to establish the consistency of treatment effects between the specific region and the entire group.
    日期: 2014-03
    關聯: Journal of Biopharmaceutical Statistics. 2014 Mar;24(2):254-271.
    Link to: http://dx.doi.org/10.1080/10543406.2013.859150
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=1054-3406&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000333938500003
    Cited Times(Scopus): http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=84896756622
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