著者

渡邉 裕之 松下 泰之 渡辺 篤 前田 敏郎 温井 一彦 小川 嘉正 澤 淳悟 前田 博

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.25, no.1, pp.37-60, 2004-06-30 (Released:2012-02-08)

参考文献数

35

被引用文献数

6 19

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It is very important to provide safety information of new drugs to physicians and patients as soon as possible after the early postmarketing period. For that purpose, it is important to appropriately collect and analyze the spontaneous reports accumulated in databases of companies and regulatory agencies. This paper reviews the analytical methods to assess spontaneous reports. Bate et al. (1998) presented Bayesian Confidence Propagation Neural Network (BCPNN) Method used by Uppsala Monitoring Centre (UMC) of the World Health Organization (WHO). DuMouchel (1999) presented Gamma-Poisson Shrinker (GPS) Program of U. S. Food and Drug Administration (FDA), and Evans et al. (2001) presented Proportional Reporting Ratios (PRR) of the Medicines Control Agency (MCA). Furthermore, DuMouchel and Pregibon (2001) extended the GPS Program, proposing the Multi-Item Gamma Poisson Shrinker (MGPS) Program, which then became the standard method for the FDA. This report also reviews the practical problems (e.g. database, duplication cases, code of Medical Dictionary for Regulatory Activities (MedDRA)) encountered in Japan.

著者

石原 幸司

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.32, no.Special_Issue, pp.S65-S75, 2010-05-31 (Released:2011-09-05)

参考文献数

8

著者

三中 信宏 岩田 洋佳 伊達 康博 曹 巍 Harshana Habaragamuwa 桂樹 哲雄 小林 暁雄 山中 武彦 櫻井 玄

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.44, no.1, pp.55-82, 2023-10-31 (Released:2023-12-06)

参考文献数

100

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This review provides a comprehensive introduction to recent developments in agricultural statistics. Agricultural statistics, which began with Fisher’s design of experiments, has developed in various directions as the nature of the data it handles has changed. The ability to rapidly measure omics data, including DNA sequences, has led to methods such as genomic selection. It has become possible to comprehensively measure even the metabolites of living organisms, giving birth to a new field called metabolomics. The development of machine learning, including deep learning, has enabled the use of image data, which has been difficult to connect with agriculture and is creating new areas such as disease diagnosis of crops. In this review, we first refer to the statistics of Fisher’s era, recall the philosophy of science in statistics, and look at the prospects of modern agricultural statistics by taking a broad overview of new fields.

著者

萩野 篤司

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.27, no.Special_Issue, pp.S8-S15, 2006-09-30 (Released:2012-01-23)

参考文献数

12

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In May 2003, the Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) issued a guidance regarding the adjustment for covariates entitled “Points to Consider on Adjustment for Baseline Covariates”. This article provides a summary of the guidance and specifically discusses the use of dynamic allocation from the viewpoint that advocates the necessity of pre-stratification in clinical trials.

著者

高橋 健一 石井 亮太 丸尾 和司 五所 正彦

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.43, no.1, pp.37-62, 2022 (Released:2023-03-24)

参考文献数

72

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The seamless phase II/III design combining phases II and III into a single trial has been shown growing interest for improving the efficiency of drug development, becoming the most frequent adaptive design type. It typically consists of two stages, the trial objectives being often different in each stage. The primary objectives are to select optimal experimental treatment group(s) in the first stage and compare the efficacy between the selected treatment and control groups in the second stage. In the final analysis, appropriate statistical methods should be applied to avoid increasing the type I error rate and selection bias. This paper reviews several statistical methods that can be applied to adaptive seamless phase II/III designs. Especially, the most representative methods such as the group sequential design approach, combination test approach, and conditional error function approach, are organized in a unified framework and the characteristics of the methods are compared. As related topics, statistical methods for the case where endpoints are different between stages 1 and 2, and the method of sample size calculation will also be discussed. Examples of actual applications are also presented.

著者

土居 正明

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.36, no.Special_Issue_2, pp.S99-S121, 2015-11-30 (Released:2016-01-15)

参考文献数

9

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For many clinical trials, including the confirmatory ones, it is usually required that the FWER should be strongly controlled. The closed testing procedure, which is proposed by Marcus et al. (1976), is a procedure for strongly controlling the FWER. It is widely used for many methods of multiplicity control, for example, Holm method, step-down Dunnett method, fixed sequence method, and gatekeeping methods, etc. This article addresses the fundamental theory of the closed testing procedure, including the proof of strongly controlling the FWER, and several examples. For introduction, Fisher’s protected LSD method is examined and improved.

著者

右京 芳文 野間 久史

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.40, no.1, pp.15-34, 2019-08-01 (Released:2019-09-18)

参考文献数

27

---

Missing data is a common problem in longitudinal clinical trials, and mixed-effects models for repeated measures (MMRM) have been widely applied to circumvent the resulting bias effectively. However, many standard inference methods of MMRM lead to the inflation of type I error rates for the tests of regression coefficient parameters when the longitudinal dataset is small and incomplete. Permutation inference methods have been established as accurate inference methods under small sample settings. In this article, we propose two effective permutation-based inference methods for the analyses using MMRM. One is the permutation of the treatment assignment variable and the other is the permutation of weighted residuals estimated by the reduced model under null hypothesis. We conducted numerical evaluations via simulation studies under realistic situations to evaluate performances of the proposed methods. The two methods generally provided valid inference results and performed relatively well compared with the current standard methods, even for small and incomplete datasets. Applications to a postnatal depression clinical trial are also presented.

著者

魚井 徹

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.18, no.1.2, pp.99-109, 1997-12-01 (Released:2012-02-27)

著者

宇野 一 松井 茂之 小山 暢之

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.21, no.Special_Issue, pp.S125-S149, 2000-06-30 (Released:2012-01-23)

参考文献数

57

著者

河津 優太 土田 潤 安藤 宗司 平川 晃弘 寒水 孝司

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.42, no.1, pp.55-64, 2021 (Released:2022-04-22)

参考文献数

11

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Phase I oncology clinical trials are designed to evaluate the safety of test drug/s and to determine the recommended dose for subsequent trials. However, the method to determine the required number of participants (sample size) has not been sufficiently developed for these dose-finding studies. The usual approach involves time-consuming calculations using numerical experiments to establish the required sample size that will allow the determination of accurate recommended dose of the test drug/s. In this study, we propose a time-saving method to determine the sample size. This method uses an alternative index of the proportion to accurately select the recommended dose. In the numerical experiments, we compared the performances (sample size, proportion of correctly selected recommended dose, and calculation time for the determination of sample size) of the proposed method with those of the conventional method. The sample size and the proportion of correctly selected recommended dose, determined by the proposed method, were slightly different from those calculated using the conventional method. The calculation time of the proposed method was consistently shorter than that of the conventional method. These results suggest that the proposed method can be used to roughly estimate the sample size of phase I oncology studies.

著者

濱口 雄太 松嶋 優貴 野間 久史

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.42, no.1, pp.33-54, 2021 (Released:2022-04-22)

参考文献数

26

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In evidence-based medicine, meta-analysis is a relevant method for research syntheses. Random-effects model has been a primary statistical tool for meta-analysis since it enables a quantitative evaluation of the treatment effect accounting for the between-studies heterogeneity. In practices of meta-analyses, some studies may have markedly different characteristics from the others and such “outlying” studies might yield misleading results. For this problem, although several frequentists’ methods to detect outlying studies have been developed, there has been no effective Bayesian method to detect outlying studies and to assess their influence. In this article, we proposed influence diagnostic methods for meta-analyses using four Carlin-Louis-type influence measures; (a) relative distance, (b) standardized residual, (c) Bayesian p-value, and (d) scale parameters in scale mixture models. We also demonstrated the practical effectiveness of these proposed methods through applications to four meta-analyses for a spinal manipulative therapy, renin angiotensin system inhibitors, a known history of gestational diabetes, and antenatal corticosteroids.

著者

張 方紅 青木 誠 柿爪 智行

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.42, no.1, pp.15-32, 2021 (Released:2022-04-22)

参考文献数

35

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After the implementations of the revised “Ministerial Ordinance on Good Post-marketing Study Practice for Drugs” in April 2018, the Pharmaceuticals and Medical Devices Agency requires to conduct more efficient and effective post-marketing study (PMS). To design a PMS, it is important to define a research question based on the information of clinical trials, the characteristics of target diseases and the product profile. Nevertheless, designing a PMS faces some key challenges: (1) it is difficult to specify a research question due to strong exploratory aspects; (2) the results of PMS are not so useful for practical pharmacovigilance activities despite spending a huge resource/cost and (3) the accumulated experience and knowledge from existing clinical trials are not utilized. It is potentially difficult to address those challenges by the frequentist approach, although it can be used in PMS. We propose a Bayesian approach to address these three key challenges for a single arm PMS. Under the Bayesian approach, we can set and answer a research question in a probabilistic way and then offer some added values to frequentist method. Moreover, we discuss the sample size calculation for the research question based on the Bayesian approach and practical issues of implementing the Bayesian approach.

著者

加茂 憲一 福井 敬祐 坂本 亘 伊藤 ゆり

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.41, no.2, pp.93-115, 2021 (Released:2021-05-11)

参考文献数

52

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In this paper, we implement a micro-simulation (MS) model for colorectal cancer and report the process of the MS model applying to Japanese data. As an advantage of MS, it is possible to evaluate the effects of interventional cancer control program based on various scenario setting. Although there are many advanced MS projects in policy making in other countries, they are still on the way of developing in Japan. Then, we have tried to construct a colorectal cancer MS model in Japan. The purpose of this paper is to describe the process of colorectal cancer MS in Japan as a useful manual for future reference, and to introduce an on-going research project and future possibility of research extensions.

著者

渡辺 秀章 田崎 武信

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.27, no.Special_Issue, pp.S33-S44, 2006-09-30 (Released:2012-01-23)

参考文献数

21

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In clinical trials, missing data often happens for a variety of reasons, such as dropouts, making it difficult to analyze the primary variable measured longitudinally and to interpret the results of the primary analysis. While handling missing data sometimes causes bias in the results, there have been no established statistical approaches applied to missing data in appropriate situations. In November 2001, Committee for Proprietary Medical Product of the European Medicines Agency, issued “Points to Consider (PtC) on Missing Data”, which focuses on several points that should be taken into account when handling missing data in clinical trials. In this paper, we review the contents of this PtC, which assumes that the primary analysis is based on the ITT principle, and discuss some of the approaches for handling missing data and the difficulties in interpreting these results.

著者

談 小健 高野 泰 岸野 洋久

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.20, no.2, pp.167-179, 2000-03-30 (Released:2012-02-27)

参考文献数

9

被引用文献数

1 1

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Paired comparison is popular in preference trials. The estimated Scores have high accuracy, even if the data include measurement errors. However, incomplete comparison becomes inevitable, especially when the number of objects to be scored is large. In such cases, high precision by paired comparison is not guaranteed. In this paper, we propose a maximum likelihood estimation of scores, based on four-fold choice data. An empirical study of flower preference showed that the method of four-fold choice takes about the same time as a paired comparison, and the estimated scores were almost the same for the two procedures. It was clearly shown, by numerical simulation, that the precision of the estimated score of the most preferred object does not decrease with an increased number of objects to be compared in the method of four-fold choice. This is in great contrast to the paired comparison method. The estimated scores of less preferred objects have larger variances in the method of four-fold choice, whereas those from paired comparisons have similar variances for all objects. Thus, the four-fold choice method is effective when the scores of Most preferred objects are matters of concern.

著者

杉浦 賢吉 上坂 浩之

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, pp.33-52, 2008-07-01

参考文献数

13

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Adaptive design is one of the most active research areas in clinical statistics for the last decade. This paper will give an introduction to the theory of two stage adaptive designs based on the pioneering articles by Bauer and Kohne (1994) and Proschan and Hunsberger (1995). As an application of Bauer and Kohne method, Bauer and Kiser method for two stage adaptive dose selection procedure in a dose response study is illustrated. Two actual examples of a confirmatory two treatments trial and a dose response study are briefly given.

著者

法隆 大輔 林 武司

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.33, no.2, pp.125-143, 2013-02-28 (Released:2013-03-07)

参考文献数

23

被引用文献数

3 7

---

Definition of similarity is required for clustering co-expressed genes or estimating gene regulatory network from gene expression data. Pearson correlation coefficient and mutual information are the popular measures to evaluate similarity between gene expression profiles. To investigate which measure is appropriate for evaluating similarity between gene expression profiles, we have compared these two measures using Gene ontology annotation similarity. Genes that have similar Gene ontology annotations can be interpreted that they have commonality in biological processes or molecular functions. The results showed that the better similarity measure is different depending on the purpose of the analysis or from which organism the data derived. In the case of evaluating similarities among more than three genes, mutual information was a better similarity measure for the data derived from multicellular organisms, though Pearson correlation coefficient was a better similarity measure for the data derived from unicellular organisms. In the case of finding genes whose transcripts have similar functions or genes that participate to similar processes, Pearson correlation coefficient was always a better measure.

著者

大橋 靖雄

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.28, no.Special_Issue_1, pp.S75-S86, 2007-10-01 (Released:2011-09-25)

参考文献数

20

著者

和泉 志津恵 藤井 良宜 田中 佐智子

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.32, no.2, pp.97-118, 2012-03-31 (Released:2012-06-08)

参考文献数

75

被引用文献数

1

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The importance of cohort studies in order to explore diseae causes has been recognized. When a disease is rare, the cohort studies need a long follow-up period, a high budget, and a large number of participants in the target population. A nested case-control study design is proposed as a supplementary study conducted within a cohort, efficiently using the information from the cohort study. In the present paper we explain the sampling design of controls and the methods of data analysis in a nested case-control study. In addition we explain the methods of sample size and power calculation to design the nested case-control study. Further, we introduce some methods for the data with missing values in covariates, and we report the performance assessment from the application of these methods to the nested case-control study data.

著者

坂巻 顕太郎

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.36, no.Special_Issue_2, pp.S147-S164, 2015-11-30 (Released:2016-01-15)

参考文献数

18

---

Gatekeeping procedures and mixture procedures are multiple testing procedures controlling the familywise error rate in the strong sense, and deal with hierarchically ordered multiple objectives in clinical trials. As applications of gatekeeping procedures and mixture procedures have been increasing, methodological issues and examples with respect to these procedures have drawn attention. In this article, we show the relationship of the closed testing procedure and gatekeeping procedures, the relationship of gatekeeping procedures and mixture procedures.