國家衛生研究院 NHRI:Item 3990099045/3089
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    题名: A two-stage design for drug screening trials based on continuous endpoints
    作者: Tsou, HH;Hsiao, CF;Chow, SC;Liu, JP
    贡献者: Division of Biostatistics and Bioinformatics
    摘要: Pharmaceutical development is a risky, complex, costly, and time-consuming endeavor More than half of development duration is spent in clinical trials. Despite the large number of potential candidates available and the lengthy process of clinical development, the success rate is disappointing. Hence, there is an urgent need for new strategies and methodology for efficient and cost-effective designs to screen potential candidates based on the idea of the proof of the concept for efficacy in a rapid and reliable manner to minimize the total sample size and hence to shorten the duration of the trials. In this article, a two-stage screening design based on continuous efficacy endpoints is proposed. The proposed two-stage screening designs minimize the expected sample size if the new candidate has low efficacy activity subject to the constraint upon the type I and type II error rates. In addition, two-stage screening designs that minimize the maximum sample size (minimax) are presented. Tables of two-stage and minimax designs for various combinations of design parameters are also provided. Applications to the phase 1 and 2 stages of clinical development are illustrated.
    关键词: Health Care Sciences & Services;Pharmacology & Pharmacy
    日期: 2008
    關聯: Drug Information Journal. 2008;42(3):253-262.
    Link to: http://www.nxtbook.com/nxtbooks/dia/druginformationjournal0508/index.php
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000255547800007
    Cited Times(Scopus): http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=44649200472
    显示于类别:[蕭金福] 期刊論文
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