| 研究生: |
何錫勳 Ho, Hsi-Hsun |
|---|---|
| 論文名稱: |
二階段設計中母體平均數之估計 Estimation of Population Mean for Simon Designs |
| 指導教授: |
嵇允嬋
Chi, Yun-Chan |
| 學位類別: |
碩士 Master |
| 系所名稱: |
管理學院 - 統計學系 Department of Statistics |
| 論文出版年: | 2006 |
| 畢業學年度: | 94 |
| 語文別: | 中文 |
| 論文頁數: | 36 |
| 中文關鍵詞: | 連續型療效反應 、截斷分布 、二階段設計 |
| 外文關鍵詞: | Two-stage design, Continuous endpoint, Truncated distribution |
| 相關次數: | 點閱:263 下載:3 |
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在藥物的第二期臨床實驗中,為了降低受試者用藥後的風險,常採用Simon二階段設計來進行實驗。在這個設計中,實驗進行方式為,在第一階段中受試者用藥後的療效反應之平均達到預先設定值時,才會進行第二階段的實驗。就統計分析師的立場而言,當實驗順利進行完兩個階段,此時第一階段反應之平均會服從某種截斷分布,例如截斷常態分布。若直接採用兩個階段實驗中全部受試者的平均反應,來估計藥物的療效,則由於未考慮到截斷的影響,很可能會產生偏誤。所以本論文將分別在參數方法及非參數方法下修正截斷所造成的影響,並利用模擬方式探討這些方法的準確性。
Generally, Simon two-stage designs are usually employed in Phase II clinical trails to avoid giving patients an ineffective drug. In the design, if the average of patients’ responses at the first stage reaches to a pre-specified value, then the second stage is allowed to continue. From statistician’s viewpoint, the average of responses at the first stage follows some truncated distribution, such as truncated normal distributions. Because of ignoring the truncation effect, the average of all responses in two stage experiments is an overestimated estimator. Therefore, parametric and nonparametric estimation methods are applied to take into account for the truncation effect. Furthermore, a simulation study is conducted to investigate the accuracy of these methods.
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