國家衛生研究院 NHRI:Item 3990099045/3089
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    Please use this identifier to cite or link to this item: http://ir.nhri.org.tw/handle/3990099045/3089


    Title: A two-stage design for drug screening trials based on continuous endpoints
    Authors: Tsou, HH;Hsiao, CF;Chow, SC;Liu, JP
    Contributors: Division of Biostatistics and Bioinformatics
    Abstract: 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.
    Keywords: Health Care Sciences & Services;Pharmacology & Pharmacy
    Date: 2008
    Relation: 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
    Appears in Collections:[Chin-Fu Hsiao] Periodical Articles
    [Hsiao-Hui Sophie Tsou] Periodical Articles

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