著者

渡橋 靖

出版者

日本計量生物学会

雑誌

計量生物学 (ISSN:09184430)

巻号頁・発行日

vol.29, no.Special_Issue_1, pp.S61-S68, 2008-07-01 (Released:2011-12-02)

参考文献数

20

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The ICH E14 guideline provides recommendation to assess QT interval prolongation and proarrhythmic potential of non-antiarrhythmic drugs in clinical studies. As there exist many statistical issues in the clinical evaluation of QT prolongation, electrocardiograms, background information of the guideline and QT interval correction methods are described for introduction. Because of the inverse relationship to heart rates, QT intervals are corrected for heart rates in order to obtain a variable which is independent of heart rate. Population-derived correction, subject-specific correction, and other correction methods are introduced. Assumptions of each correction method and its properties are discussed. Study design should be considered to collect appropriate data and estimate accurate heart rate correction formulae.

著者

小宮山 靖 越水 孝 菅波 秀規 酒井 弘憲 渡橋 靖 東宮 秀夫

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.40, no.6, pp.303-310, 2009 (Released:2009-12-25)

参考文献数

22

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A PhRMA Working Group on adaptive clinical trial designs has been formed to investigate and facilitate opportunities for wider acceptance and usage of adaptive designs and related methodologies. A White Paper summarizing the findings of the group is currently in preparation. This article is an Executive Summary of that full White Paper; it summarizes the findings and recommendations of the group. Logistic, operational, procedural, and statistical challenges associated with adaptive designs are addressed. Three particular areas where adaptive designs can likely be utilized beneficially are discussed: dose finding, seamless Phase II/III trial designs, and sample size reestimation.