Japanese journal of biometrics最新文献_第5页

Case-Only Method to Estimate the Relative Incidence of Adverse Events for Comparison of Two Treatments: Application in Disseminated Intravascular Coagulation Patients 评估两种治疗方法相对不良事件发生率的病例方法:在弥散性血管内凝血患者中的应用

Japanese journal of biometrics Pub Date : 2015-07-20 DOI: 10.5691/JJB.36.13

Chris Fook Sheng Ng, Y. Matsuyama, Y. Ohashi

引用次数: 0

Operating Characteristics of Restrictions on Skipping Dose Level for Adaptive Dose-Finding Method in Two-Agent Phase I Trials 自适应剂量测定方法在双药I期试验中跳过剂量水平限制的操作特征

Japanese journal of biometrics Pub Date : 2015-07-20 DOI: 10.5691/JJB.36.1

A. Hirakawa, S. Matsui

引用次数: 0

母集団薬物動態解析の基礎：線形混合効果モデル・非線形混合効果モデルの数理总体药代动力学分析的基础:线性混合效果模型和非线性混合效果模型的数理

Japanese journal of biometrics Pub Date : 2015-06-30 DOI: 10.5691/JJB.36.S33

船渡川伊久子, 隆船渡川

引用次数: 0

Two-Phase, Three-Stage Adaptive Designs in Clinical Trials 临床试验中的两阶段、三阶段适应性设计

Japanese journal of biometrics Pub Date : 2015-01-31 DOI: 10.5691/JJB.35.69

H. Uesaka, T. Morikawa, A. Kada

{"title":"Two-Phase, Three-Stage Adaptive Designs in Clinical Trials","authors":"H. Uesaka, T. Morikawa, A. Kada","doi":"10.5691/JJB.35.69","DOIUrl":"https://doi.org/10.5691/JJB.35.69","url":null,"abstract":"In clinical investigator initiated clinical trials, we frequently encounter the situation where it is very difficult to estimate the effect size and the clinically meaningful difference between the treatment and control groups. In this paper we explore various two-phase, three-stage adaptive designs which can be applied to this situation. The first phase determines whether the trial should proceed or not. If the decision is to proceed, then the sample size is re-estimated. The second phase consists of two stages, but the sample size is not re-estimated. We introduce hybrid and alpha-split designs, adding to two existing adaptive designs: Bauer-Köhne design and Lehmacher-Wassmer design. Main findings are: 1) the differences in the overall powers and the average sample number (ASN)s among these designs are small, except for the design which includes O’Brien-Fleming boundaries and the alpha-split design, 2) the two-phase, three-stage design suffers a relative loss of power by 15% but the ASN is less than 50%, as compared to the single stage design under the optimal condition, 3) two-phase, three-stage design compares with the three-stage group sequential design. We conclude that the design can be a candidate when there is no useful information on the effect size.","PeriodicalId":365545,"journal":{"name":"Japanese journal of biometrics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125667461","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A New Procedure of One-Sided Test in Clinical Trials with Multiple Endpoints 多终点临床试验单侧检验的新方法

Japanese journal of biometrics Pub Date : 2014-08-31 DOI: 10.5691/JJB.35.17

Y. Nakazuru, T. Sozu, C. Hamada, I. Yoshimura

引用次数: 2

Group Comparisons Involving Zero-Inflated Count Data in Clinical Trials 临床试验中涉及零膨胀计数数据的组间比较

Japanese journal of biometrics Pub Date : 2014-02-28 DOI: 10.5691/JJB.34.53

K. Togo, Manabu Iwasaki

{"title":"Group Comparisons Involving Zero-Inflated Count Data in Clinical Trials","authors":"K. Togo, Manabu Iwasaki","doi":"10.5691/JJB.34.53","DOIUrl":"https://doi.org/10.5691/JJB.34.53","url":null,"abstract":"In clinical trials, outcomes of count data sometimes have excess zeros. When a test drug is compared to a control, zero-inﬂated data may be ignored or interest is taken only in the proportion of zero counts. By applying the two-part model, Lachenbruch (2001a) suggested a test statistic called the two-part statistic that combines the test statistics of the zero part and the non-zero part. The test for the zero part is the chi-square test. The test for the non-zero part may be a Wilcoxon test, a t -test, etc. This article proposes methods for calculating the sample size and power for the two-part statistic with zero-inﬂated Poisson data. We developed the methods of sample size and power for the two-part statistic using the Wilcoxon test adjusted for ties. The relationship between the non-zero part and zero-truncated Poisson distribution is also described. Furthermore, we examine the power of the two-part statistic, conventional methods, and the zero-inﬂated Poisson model. in which patients do not recover but have a small value of the outcome that is zero by chance. The zero-inﬂated Poisson (ZIP) distribution or zero-inﬂated negative binomial distribution can be applied to count data with excess zeros. This article focuses on the ZIP distribution. The ZIP distribution has two parameters; λ is the Poisson parameter and ω expresses the extent of zero-inﬂation compared with zero counts that occur from the Poisson distribution.","PeriodicalId":365545,"journal":{"name":"Japanese journal of biometrics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2014-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116004574","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

An Extension of the Holm Procedure Based on Partitioning Principle for Adaptive Treatment Selection Designs with Structured Hypotheses 基于分割原则的Holm程序在结构化假设自适应治疗选择设计中的推广

Japanese journal of biometrics Pub Date : 2014-02-28 DOI: 10.5691/JJB.34.67

Toshifumi Sugitani

引用次数: 1

がん第 I 相試験における 2 剤併用療法の用量探索法：最近の展開癌症I期试验中两药联合疗法的剂量搜索法:最近的展开

Japanese journal of biometrics Pub Date : 2014-02-28 DOI: 10.5691/JJB.34.81

晃弘平川, 茂之松井

引用次数: 0

Multiple Comparison Procedures in Multi-Sample Exponential Models 多样本指数模型中的多重比较程序

Japanese journal of biometrics Pub Date : 2013-08-31 DOI: 10.5691/JJB.34.1

T. Shiraishi

{"title":"Multiple Comparison Procedures in Multi-Sample Exponential Models","authors":"T. Shiraishi","doi":"10.5691/JJB.34.1","DOIUrl":"https://doi.org/10.5691/JJB.34.1","url":null,"abstract":"We construct multiple comparisons procedures in k exponential populations. Exact theory and asymptotic theory of simultaneous confidence intervals and multiple comparisons tests are discussed. First, we consider multiple comparisons for the differences among parameters. We can give the Tukey-Kramer type multiple test procedure based on estimators of k means. However, the degree of conservativeness for the multiple tests depends on unknown mean parameters. Therefore, multiple tests based on the logarithm transformation of estimators are proposed. It is found that the degree of conservativeness for the proposed tests is controlled by the sample sizes. Furthermore, the closed testing procedure, more powerful than the REGW (Ryan/Einot-Gabriel/Welsch) tests, is proposed. Simultaneous confidence intervals for the differences among the logarithms of parameters are discussed. Next, for the multiple comparisons with a control, we propose the multiple test procedures. It is shown that the proposed multiple test is superior to the tests based on the Bonferroni inequality asymptotically. A sequentially rejective procedure is derived under unequal sample sizes. Last, we consider multiple comparisons for all parameters. The exact single-step multiple comparison procedures based on the upper 100α% points the χ2-distribution are proposed. The asymptotic theory for the multiple comparisons is discussed. Especially sequentially rejective procedures can be constructed in the asymptotic theory.","PeriodicalId":365545,"journal":{"name":"Japanese journal of biometrics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2013-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115354888","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Statistical Issues in Clinical Trials with Multiple Primary Endpoints 多主要终点临床试验中的统计问题

Japanese journal of biometrics Pub Date : 2013-08-31 DOI: 10.5691/JJB.34.35

T. Sozu, Tomoyuki Sugimoto, T. Hamasaki

引用次数: 0