8 0 0 0 OA 臨床試験における被験者数再設定—方法論の概説と統計学的留意点—
- 著者
- 上村 鋼平
- 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.1, pp.77-99, 2012-08-31 (Released:2012-10-02)
- 参考文献数
- 74
Recently, it is becoming more challenging to cope with low success probabilities, much cost and severe competitions in a new drug development. An adaptive design is considered to be a promising tool for efficient development for its various types of adaptations and applications in multiple development stages. However, its flexibility does not necessarily make the development more efficient and it may always allow a risk of operational bias to use such a design. Thus, to consider the specific benefit and risk of each adaptive design using quantitative measures under a concrete setting, it is important to make intensive discussions and to share experiences between each side persons in charge. In this review, focusing on sample size re-estimation which is a relatively simple and basic adaptive design, I will give some outlines of methods and review statistical points to consider.
- 著者
- 上村 鋼平
- 出版者
- 日本計算機統計学会
- 雑誌
- 日本計算機統計学会大会論文集 (ISSN:21895821)
- 巻号頁・発行日
- vol.27, pp.95-98, 2013
1 0 0 0 OA 群間差に関する事前情報を考慮したベイズ流被験者数再設定方法と新しい評価系の提案
- 著者
- 上村 鋼平
- 出版者
- 東京大学大学院医学系研究科公共健康医学専攻 (専門職学位課程)生物統計学分野
- 巻号頁・発行日
- 2009-03-23
報告番号: 甲24918 ; 学位授与年月日: 2009-03-23 ; 学位の種別: 課程博士 ; 学位の種類: 博士(保健学) ; 学位記番号: 博医第3338号 ; 研究科・専攻: 医学系研究科健康科学・看護学専攻