著者

佐藤 恵子 岩崎 学 菅波 秀規 佐藤 俊哉 椿 広計

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.1, pp.37-53, 2014-08-31 (Released:2014-10-15)

参考文献数

18

被引用文献数

1 1

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All statisticians are expected to produce statistical outcomes of high quality and reliability. To ensure reliability in statistical performance and outcomes and to meet societal expectations, certain standards of conduct (SOC) must be established such that individual statisticians embrace their own principles and so that the community of statisticians as a whole functions with more self-control.In 2008, the Biometric Society of Japan began revision of the code of conduct, and the working group drafted an SOC. This particular draft re.ected the opinions of statisticians and the basic concepts which aligned well with ethical guidelines of the American Statistical Association and the International Statistical Institute. As forced guidelines rarely result in full compliance and increased ethical conduct, the SOC offers a framework to encourage individual biostatisticians to establish and hold their own principles and to act responsibly with integrity.The SOC comprises a preamble, mission statement, values, ten principles and background information. The draft SOC was approved by the Council of the Biometric Society of Japan in November 2013.The SOC will help statisticians improve their capacity to perform sound statistical practices, improve the working environment, cultivate the next generation of statisticians with professionalism, and acquire societal trust.

著者

小宮山 靖 越水 孝 菅波 秀規 酒井 弘憲 渡橋 靖 東宮 秀夫

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.40, no.6, pp.303-310, 2009 (Released:2009-12-25)

参考文献数

22

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A PhRMA Working Group on adaptive clinical trial designs has been formed to investigate and facilitate opportunities for wider acceptance and usage of adaptive designs and related methodologies. A White Paper summarizing the findings of the group is currently in preparation. This article is an Executive Summary of that full White Paper; it summarizes the findings and recommendations of the group. Logistic, operational, procedural, and statistical challenges associated with adaptive designs are addressed. Three particular areas where adaptive designs can likely be utilized beneficially are discussed: dose finding, seamless Phase II/III trial designs, and sample size reestimation.