系統識別號 U0026-1406201722344500 論文名稱(中文) 基於連續點的變假設藥物檢視試驗之貝葉斯兩階段設計 論文名稱(英文) Bayesian Two-Stage Design for Drug Screening Trials with Switching Hypothesis Tests based on Continuous Endpoints 校院名稱 成功大學 系所名稱(中) 統計學系 系所名稱(英) Department of Statistics 學年度 105 學期 2 出版年 106 研究生(中文) 孫楠 研究生(英文) Nan Sun 學號 R26043013 學位類別 碩士 語文別 英文 論文頁數 26頁 口試委員 指導教授-溫敏杰口試委員-高正雄口試委員-吳國龍口試委員-吳宗正 中文關鍵字 連續點  貝葉斯  變假設 英文關鍵字 continuous endpoints  Bayesian  changing hypothesis 學科別分類 中文摘要 在第二階段臨床試驗中，Simon (1989) 二階段設計是最經典和廣為人知的單臂設計之一。Simon 兩階段設計解決的問題是檢測某種試驗藥物的反應機率是否低於某一低水準，其檢測點必须是二元的。而Tsou 等人(2008) 對於某一試驗藥物有效性的平均水準是否低於某一低水準的單臂設計，在將二元點改為連續點方面，為Simon 兩階段設計的一個修正。Shi 和Yin (2016)在很多方面修改了Simon 兩階段設計：一是改變第一階段的決策法則（與Simon (1989) 檢測的假設相同），二是在第二階段將單臂試驗改為雙臂試驗；三是在第二階段使用貝葉斯方法做決策。我們的設計在將二元點改為連續點方面，可視為Shi 和Yin (2016) 的延伸，即將Shi 和Yin (2016) 以及Simon (1989) 中某種藥物的反應機率改為Tsou (2008) 等人的某種藥物的有效性的平均水準。 英文摘要 In Phase II clinical trials, Simon’s (1989) two-stage design is one of the most classical and well-known designs. The question Simon’s two-stage design tackles with is to test whether the response probability of an experimental drug is less than some uninteresting level, which demands that the endpoints are binary. Besides, Simon’s design is a single-arm design. Tsou et al. (2008) is to test whether the mean level of efficacy of an experimental drug is less than some uninteresting level, which makes itself a revision of Simon’s two-stage design in the aspect of changing binary endpoints to continuous endpoints and also a single-arm design. Shi and Yin (2016) modifies Simon’s two-stage design in several aspects: the first is to change the decision rule in the first stage with the same hypothesis tested as Simon (1989), the second is to change single-arm trial to double-arm trial in the second stage, and the third is to use Bayesian method to make a decision in the second stage. Our design is an extension of Shi and Yin (2016) since we change the binary endpoints, i.e., the response probability in Shi and Yin (2016) and Simon (1989), to continuous endpoints in Tsou et al. (2008), which is the mean level of efficacy of a drug. 論文目次 Cover i Oral presentation document ii Chinese version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii English version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii Abstract (Chinese) iv Abstract (English) v Acknowledgments vi Table of Contents vii List of Tables viii List of Figures ix Chapter 1. Introduction 1 Chapter 2. Bayesian Two-Stage Design with Continuous Endpoints 3 2.1 Single-to-Double Arm Transition . . . . . . . . . . . . . . . . . . . . . 3 2.2 Frequentist Error Rates . . . . . . . . . . . . . . . . . . . . . . . . . . 6 2.3 Bayesian Error Rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Chapter 3. Monte Carlo Approximation of Error Rates 11 Chapter 4. Determination of Design Parameters 14 Chapter 5. Simulation Studies 16 Chapter 6. Discussion 18 參考文獻 Hoff P D. A first course in Bayesian statistical methods. Springer Science & Business Media, 2009. Shi H, Yin G. Bayesian Two-Stage Design for Phase II Clinical Trials with Switching Hypothesis Tests. Bayesian Analysis, 2016. Simon R. Optimal two-stage designs for phase II clinical trials. Controlled clinical trials, 1989, 10(1): 1-10. Tsou H H, Hsiao C F, Chow S C, Liu J. P. A two-stage design for drug screening trials based on continuous endpoints. Drug Information Journal, 2008, 42(3): 253- 262. 論文全文使用權限 同意授權校內瀏覽/列印電子全文服務，於2020-01-01起公開。同意授權校外瀏覽/列印電子全文服務，於2020-01-01起公開。

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