Japanese journal of biometrics最新文献_第8页

Practical Considerations in Sample Size Determination of Japanese Subgroup for a Multi-Regional Oncology Clinical Trial 多区域肿瘤临床试验中日本亚组样本量确定的实际考虑

Japanese journal of biometrics Pub Date : 2009-12-31 DOI: 10.5691/JJB.30.81

Sachio Ogawa, R. Sekiguchi, H. Uesaka

{"title":"Practical Considerations in Sample Size Determination of Japanese Subgroup for a Multi-Regional Oncology Clinical Trial","authors":"Sachio Ogawa, R. Sekiguchi, H. Uesaka","doi":"10.5691/JJB.30.81","DOIUrl":"https://doi.org/10.5691/JJB.30.81","url":null,"abstract":"For Japanese pharmaceutical companies, one of the critical issues in the design of multi-regional clinical trials (MRCT) is the number of Japanese patients. In the document issued by the Ministry of Health, Labour and Welfare (MHLW) in 2007, “Basic principles on Global Clinical Trials,” an issue was raised about the Japanese subgroup sample size and the importance of “consistency of results.” Ideas on how to calculate the sample size of a given region and the regions overall have been proposed by Uesaka (2006, 2009). For this purpose, he identified two types of consistency criteria and two types of efficacy criteria. For both efficacy and consistency these types consist of either 1) comparing the results of a specific region with those of the other regions combined, or 2) comparing the results of a specific region with those of the regions overall. Based on the efficacy criterion 2, Sekiguchi et al. (2007) examined the sample size of the Japanese subgroup in an oncology MRCT.In this study, we present a simulation that shows the relationship of Japanese subgroup sample size to both types of efficacy criteria in an oncology MRCT.","PeriodicalId":365545,"journal":{"name":"Japanese journal of biometrics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2009-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132533362","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

Relationship between Intraclass and Concordance Correlation Coefficients: Similarities and Differences 类内相关系数与一致性相关系数的关系:异同

Japanese journal of biometrics Pub Date : 2009-06-30 DOI: 10.5691/JJB.30.35

T. Kusunoki, J. Matsuoka, H. Ohtsu, T. Kagimura, Hidekazu Nakamura

{"title":"Relationship between Intraclass and Concordance Correlation Coefficients: Similarities and Differences","authors":"T. Kusunoki, J. Matsuoka, H. Ohtsu, T. Kagimura, Hidekazu Nakamura","doi":"10.5691/JJB.30.35","DOIUrl":"https://doi.org/10.5691/JJB.30.35","url":null,"abstract":"The intraclass and concordance correlation coefficients (ICC and CCC) are popular indices of reliability or agreement for continuous variables. While various versions of ICC are used according to study design, the CCC is solely used as an index of agreement among fixed raters. However, we considered other versions of CCC in connection with all types of ICC, as classified by McGraw and Wong (Psychological Methods 1: 30-46, 1996), and examined the similarities and differences between ICCs and CCCs. Because they were found to be compatibly similar to each other, it is considered that CCC has a wider range of applicability and ICC shares the framework of CCC including factors of precision and accuracy as well as applicability to pairwise sub-analysis among multiple raters. Although it is said that some version of ICC should selectively be used according to study purpose and design, useful information is added by the combined use with the other ICCs and CCCs and by pairwise sub-analysis. For a better understanding of the study results, additional information concerning the possible factors which could lower or enhance precision and/or accuracy will be necessary.","PeriodicalId":365545,"journal":{"name":"Japanese journal of biometrics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2009-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132442039","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: 3

A Case Study on the Optimal Design of Clinical Pharmacology Trials with Restrictions on the Dosing Schedule 限制给药方案的临床药理学试验优化设计案例研究

Japanese journal of biometrics Pub Date : 2009-06-30 DOI: 10.5691/JJB.30.1

Kazuyo Kikuchi, C. Hamada, I. Yoshimura

引用次数: 0

Influence of Random Effects Incorporated in the Analysis of Pharmacological Data Based on a Four-parameter Logistic Model 基于四参数Logistic模型的药理学数据分析中纳入随机效应的影响

Japanese journal of biometrics Pub Date : 2009-06-30 DOI: 10.5691/JJB.30.17

M. Yamada, C. Hamada, I. Yoshimura

{"title":"Influence of Random Effects Incorporated in the Analysis of Pharmacological Data Based on a Four-parameter Logistic Model","authors":"M. Yamada, C. Hamada, I. Yoshimura","doi":"10.5691/JJB.30.17","DOIUrl":"https://doi.org/10.5691/JJB.30.17","url":null,"abstract":"In the later phases of selecting candidate chemicals for drug development, pharmacological experiments are conducted using animal organs or human peripheral blood cells. In these experiments, data analysis is often performed on the basis of mixed-effect models so that the individuality effect can be incorporated in the dose-response relationship. This paper studied the influence of the incorporation of random effects on parameters in a logistic model intended for analysis, with the assumption that the dose-response relationship is really described by a four-parameter logistic model. Using Monte-Carlo simulation experiments, we compared the performances of eight models in which various mixed-effects were incorporated. In each of the eight analysis models, five methods of calculation, namely, the standard two-stage method (STS), first-order approximation method (FOA), Laplacian approximation method (LAP), Monte Carlo integration method (MCI), and Gaussian quadrature method (GAU), were applied to the simulation data. The eight analysis models and five estimation methods were compared, using estimability and the deviation of estimates from the true value as the criteria. The results revealed the analysis model incorporating the random effect on only the maximum response to be the best. The results also indicated that the FOA, LAP, MCI, and GAU methods had almost the same performances for this analysis model. The authors recommend LAP as the preferred method because of the simplicity of its calculation.","PeriodicalId":365545,"journal":{"name":"Japanese journal of biometrics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2009-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121425319","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

Bayesian Design of Single-arm Clinical Trials with Binary Endpoints : A Review 双终点单臂临床试验的贝叶斯设计综述

Japanese journal of biometrics Pub Date : 2008-12-01 DOI: 10.5691/JJB.29.111

S. Teramukai

引用次数: 1

A Poisson Mixed Effects Model for Investigating the Exposure-by-Cohort Interaction: A Gibbs Sampling Approach 研究暴露-群体相互作用的泊松混合效应模型:吉布斯抽样方法

Japanese journal of biometrics Pub Date : 2008-12-01 DOI: 10.5691/JJB.29.61

Seitaro Yoshida, Y. Matsuyama, Y. Ohashi, H. Ueshima

引用次数: 0

A Spatial Scan Statistic with a Restricted Likelihood Ratio 具有受限似然比的空间扫描统计量

Japanese journal of biometrics Pub Date : 2008-12-01 DOI: 10.5691/JJB.29.75

T. Tango

引用次数: 40

REML Estimation of Genetic Correlations between Sexes on Beef Carcass Traits Using a Procedure of the Average Information Algorithm 基于平均信息算法的牛肉胴体性状性别遗传相关性的REML估计

Japanese journal of biometrics Pub Date : 2008-12-01 DOI: 10.5691/JJB.29.97

A. Arakawa, H. Iwaisaki

{"title":"REML Estimation of Genetic Correlations between Sexes on Beef Carcass Traits Using a Procedure of the Average Information Algorithm","authors":"A. Arakawa, H. Iwaisaki","doi":"10.5691/JJB.29.97","DOIUrl":"https://doi.org/10.5691/JJB.29.97","url":null,"abstract":"In animal breeding and genetics applications, one topic is the evaluation of sexual dimorphism and genetic correlation between sexes. Also, in some cases, variances may be heterogeneous between levels of factors such as breed and herd as well as sex. Researches about these topics need the method for estimating relevant components of (co)variances. The objectives of this study are to derive a computational procedure of the average information algorithm for the restricted maximum likelihood estimation of the relevant (co)variances, and to estimate genetic correlations between sexes on beef carcass traits. In the current computational procedure, a derived expression for the average information matrix is used, whose elements are expressed using the solutions to the mixed model equations in a bivariate mixed linear model with heterogeneous variance and nil covariance of residuals assumed. For the current procedure, replacing the Hessian matrix by the derived average information matrix, a quasi-Newton type procedure is defined for the iterative estimation. Using simulated datasets, computing performance of the current procedure is investigated comparing with the expectation-maximization algorithm, the current procedure is applied to beef carcass traits data to estimate heritability for each sex and genetic correlation between sexes, and then the characteristics of the current procedure is concisely discussed.","PeriodicalId":365545,"journal":{"name":"Japanese journal of biometrics","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2008-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125868237","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 Application of an Adaptive Design to a Clinical Trial 适应性设计在临床试验中的应用

Japanese journal of biometrics Pub Date : 2008-07-01 DOI: 10.5691/JJB.29.S53

S. Morita

引用次数: 0

Discussion on Morikawa's Paper 对森川论文的讨论

Japanese journal of biometrics Pub Date : 2008-07-01 DOI: 10.5691/JJB.29.S107

T. Tango

引用次数: 0