Japanese Journal of Biometrics
Online ISSN : 2185-6494
Print ISSN : 0918-4430
ISSN-L : 0918-4430
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Volume 29, Issue Special_Issue_1
Displaying 1-11 of 11 articles from this issue
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Preface
Multiplicity Issues in Clinical Trials
  • Basic Principles of Multiple Test Procedures
    Tetsuhisa Miwa
    2008 Volume 29 Issue Special_Issue_1 Pages S5-S14
    Published: July 01, 2008
    Released on J-STAGE: December 02, 2011
    DOIhttps://doi.org/10.5691/jjb.29.S5
    JOURNAL FREE ACCESS
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    It is common in statistical analyses to perform two or more tests for a set of data. Then the problem of multiplicity arises. This article concisely describes the basic principles of multiple test procedures. Three fundamental methods for controlling the family-wise type I error rates are explained in a unified manner: 1) Bonferroni procedure, 2) simultaneous confidence intervals, 3) closed testing procedure.
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  • Statistical Approaches to Multiplicity Issues in Clinical Trials
    Toshihiko Morikawa
    2008 Volume 29 Issue Special_Issue_1 Pages S15-S32
    Published: July 01, 2008
    Released on J-STAGE: December 02, 2011
    DOIhttps://doi.org/10.5691/jjb.29.S15
    JOURNAL FREE ACCESS
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    This paper discusses various multiplicity issues arisen in clinical trials and possible statistical approaches to these issues. We especially stress the importance of the closed testing procedures (CTPs) in the setting of clinical trials: They include various modified Bonferroni procedures, e.g., step-down Dunnett procedure, hierarchical procedure, and Williams test. Moreover they can be even applied to adaptive designs in clinical trials. We illustrate the basic CTP procedures in detail.
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Basic Concepts and Applications of Adaptive Designs
Study Design and Statisical Evaluation of QT Designs
  • Study Design and Statistical Evaluation of QT Prolongation
    — Introduction and QT Interval Correction —
    Yasushi Orihashi
    2008 Volume 29 Issue Special_Issue_1 Pages S61-S68
    Published: July 01, 2008
    Released on J-STAGE: December 02, 2011
    DOIhttps://doi.org/10.5691/jjb.29.S61
    JOURNAL FREE ACCESS
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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.
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  • Study Design and Statistical Methodology for the Evaluation of QT Prolongation Effect
    — Examples of QT Study —
    Yoichi Satoi
    2008 Volume 29 Issue Special_Issue_1 Pages S69-S73
    Published: July 01, 2008
    Released on J-STAGE: December 02, 2011
    DOIhttps://doi.org/10.5691/jjb.29.S69
    JOURNAL FREE ACCESS
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    The thorough QT/QTc (TQT) study is a core part of the evaluation for effect of investigational drug on QT interval prolongation. The examples for the study similar to TQT study are presented in this article.
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  • Points to Consider to Design the ‘Thorough QT/QTc Study’
    Yasushi Orihashi
    2008 Volume 29 Issue Special_Issue_1 Pages S75-S82
    Published: July 01, 2008
    Released on J-STAGE: December 02, 2011
    DOIhttps://doi.org/10.5691/jjb.29.S75
    JOURNAL FREE ACCESS
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    The ‘thorough QT/QTc study’ has a critical role in evaluating QT/QTc interval prolongation of a drug. In designing the ‘thorough QT/QTc study' it is important to consider cause of variation of QT intervals and risk factors of QT prolongation, such as reliability of QT interval measurement, diurnal variation, pharmacokinetics, pharmacokinetics-pharmacodynamics relationship, age, gender, electrolyte abnormalities, concomitant drugs, concomitant diseases, etc. Choice of parallel or cross-over design and sample size determination are also discussed.
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  • Statistical Method for the Evaluation of QT Prolongation Effects in Thorough QT Study
    Yoichi Satoi, Hiroyuki Uesaka
    2008 Volume 29 Issue Special_Issue_1 Pages S83-S96
    Published: July 01, 2008
    Released on J-STAGE: December 02, 2011
    DOIhttps://doi.org/10.5691/jjb.29.S83
    JOURNAL FREE ACCESS
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    Thorough QT/QTc study is suggested by the ICH E14 guideline as one of the core components in evaluating the effect of the study drug on QT interval. This article gives an explanation for the analysis of QT/QTc data from thorough QT/QTc studies, presents some statistical issues associated with the analysis and provides some recommendations on how to handle those issues.
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