著者

寒水 孝司 杉本 知之 濱崎 俊光

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.34, no.1, pp.35-52, 2013-08-31 (Released:2013-09-20)

参考文献数

61

被引用文献数

1

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Clinical trials often employ two or more primary endpoints because a single endpoint may not provide a comprehensive picture of the intervention’s effects. In such clinical trials, a decision is generally made as to whether it is desirable to evaluate the joint effects on all endpoints (i.e., co.primary endpoints) or at least one of the endpoints. This decision defines the alternative hypothesis to be tested and provides a framework for approaching trial design. In this article, we discuss recent statistical issues in clinical trials with multiple primary endpoints. Especially, we introduce the methods for power and sample size determinations in clinical trials with co-primary endpoints, considering the correlations among the endpoints into the calculations. We also discuss the methods to alleviate conservativeness of testing co-primary endpoints.

著者

谷岡 健資 上阪 彩香 山下 陽司 大森 崇 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.35, no.2, pp.95-105, 2015-01-31 (Released:2015-03-23)

参考文献数

13

被引用文献数

1 1

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Few studies have investigated the content of introductory statistics classes for medical school students in Japan. Yet, to assure the quality of university statistics courses and develop a standard curriculum for them, it is necessary to assess the current condition of statistics education.Therefore, we collected data on the type of course (i.e., course title and targeted year for the students), field of specialty of the lecturer, course contents, and which textbooks were pre-specified for the lecture by analyzing the syllabi of statistics courses published on university websites. Next, the result of the survey is summarized. Of the 80 universities surveyed, 45 universities provided the online sylabi for the introductory statistics course. We identified 26 different course titles for statistics classes. Thirty courses (73.3%) were intended for first-year students. Eightteen courses (54.5%) provided two credits. The most common field of specialty for statistics lecturers was mathematics (43.2%). Further, we found that the course contents included various subjects related to mathematics. A total of 35 textbooks were specified. Finally, the conclusion is that mathematical concepts seem to be taught more often than statistical practice in introductory statistics classes. Further, there were large variations in each item of analysis except the target year.

著者

松村 美奈 中山 拓人 寒水 孝司

出版者

公益社団法人 日本薬学会

雑誌

YAKUGAKU ZASSHI (ISSN:00316903)

巻号頁・発行日

vol.136, no.11, pp.1563-1571, 2016-11-01 (Released:2016-11-01)

参考文献数

7

被引用文献数

4 1

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A survey of introductory statistics courses at Japanese medical schools was published as a report in 2014. To obtain a complete understanding of the way in which statistics is taught at the university level in Japan, it is important to extend this survey to related fields, including pharmacy, dentistry, and nursing. The current study investigates the introductory statistics courses offered by faculties of pharmaceutical sciences (six-year programs) at Japanese universities, comparing the features of these courses with those studied in the survey of medical schools. We collected relevant data from the online syllabi of statistics courses published on the websites of 71 universities. The survey items included basic course information (for example, the course names, the targeted student grades, the number of credits, and course classification), textbooks, handouts, the doctoral subject and employment status of each lecturer, and course contents. The period surveyed was July-September 2015. We found that these 71 universities offered a total of 128 statistics courses. There were 67 course names, the most common of which was “biostatistics (iryou toukeigaku).” About half of the courses were designed for first- or second-year students. Students earned fewer than two credits. There were 62 different types of textbooks. The lecturers held doctoral degrees in 18 different subjects, the most common being a doctorate in pharmacy or science. Some course content differed, reflecting the lecturers' academic specialties. The content of introductory statistics courses taught in pharmaceutical science programs also differed slightly from the equivalent content taught in medical schools.

著者

関山 英孝 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.37, no.2, pp.89-100, 2016-12-31 (Released:2017-05-16)

参考文献数

11

被引用文献数

2 3

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The Japanese Adverse Drug Event Report (JADER) database of the Pharmaceutical and Medical Devices Agency (PMDA) has been available to the public since 2012. The database includes reports on drug-related adverse events from pharmaceutical companies or medical institutions. It is expected to improve the proper use of pharmaceutical products through pharmacoepidemiological studies using the JADER. However, wrong results and interpretations would be derived unless the features of JADER are carefully considered before the study. However, no study has investigated JADER from the viewpoint of data cleaning.Herein, we summarized the features and precautions for use of JADER (downloaded on June 2015). For example, we found many misspellings and drug names input in various forms because of incorrect Japanese Kanji, voiced and semi-voiced dots, and half-width and full-width forms. We also found that the number of adverse events tends to increase throughout the year, with the highest number reported in the third quarter (October-December). Finally, emergency or rapid safety information (i.e., yellow letter and blue letter) and results of drug use surveys generally increase the number of adverse events reported in JADER.

著者

寒水 孝司 武蔵 優希 中山 拓人

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.38, no.2, pp.141-152, 2018 (Released:2018-05-18)

参考文献数

15

被引用文献数

1

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The American Statistical Association released a “Statement on Statistical Significance and P-Values.” There has been extensive global discussion on p-values since their use was introduced. It is necessary to eliminate or reduce significance chasing, and misin-terpretation and misuse of p-values while incorporating their proper use. This article discusses the possible causes of such problems by examining statistics education at schools of medicine, dentistry and pharmaceutical sciences in Japanese universities. In the first part of the article, we discuss the implications of the model core curricu-lum for each educational field and the reference standards of educational policy in statistics, and in the second part, we discuss the implications of the survey results for introductory statistics courses at schools of medicine, dentistry, and pharmaceutical sciences. The surveys collected relevant data from online syllabi of statistics courses along with researchers’ information published on university websites. The survey items introduced in this article include the course names, textbooks, doctoral subject and employment status of each lecturer, and course contents.

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

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.36, no.Special_Issue_2, pp.S87-S98, 2015-11-30 (Released:2016-01-15)

参考文献数

33

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Clinical trials often involve multiple objectives related to multiple settings such as treatment arms, endpoints (primary, secondary, or tertiary), and subgroups. In such clinical trials, multiplicity issues caused by multiple statistical tests need to be adequately handled throughout studies. Novel statistical methods to account for several sources of multiplicity have been developed and applied in recent clinical trials. This article briefly reviews and summarizes the multiplicity issues in clinical trials that have multiple objectives and discusses the considerations in trial design, analysis, data interpretation, and the reporting of results. Relevant textbooks, articles, an international conference, guidances, and a web site are provided as references.