了解臨床試驗的執行過程和特性，並熟悉每一階段臨床試驗的重心及所用的統計分析方法。需研讀相關文獻，熟悉相關的統計分析方法。Understand the execution process and characteristics of clinical trials, and be familiar with the focus of each phase of clinical trials and the statistical analysis methods used. It is necessary to study relevant literature and be familiar with relevant statistical analysis methods.
臨床統計是將臨床試驗中所需的統計方法加以介紹並說明如何應用。臨床試驗包含四個階段(Phase I~ Phase IV)，各階段所需的樣本數及有效性和安全性的衡量皆有對應的設計和統計方法來評估。本課程介紹如何估計Phase I 及Phase II中最大安全劑量及Phase II-Phase III中最大安全劑量及最低有效劑量，並利用多重比較方法加以鑑別。針對試驗所收集的不同屬性資料，利用適當的統計方法加以分析。
Clinical statistics introduces the statistical methods required in clinical trials and explains how to apply them. Clinical trials include four phases (Phase I ~ Phase IV). The number of samples required in each phase and the measurement of effectiveness and safety are all evaluated by corresponding design and statistical methods. This course introduces how to estimate the maximum safe dose in Phase I and Phase II and the maximum safe dose and minimum effective dose in Phase II-Phase III, and identify them using the multiple comparison method. Use appropriate statistical methods to analyze the different attribute data collected in the experiment.
1. Lawrence M. Friedman, Curt D. Furberg, and David L. DeMets, Fundamentals of Clinical Trials, 4ed, New York: Springer-Verlag, 2010.
2. Thomas D. Cook and David L. DeMets, Introduction to Statistical Methods for Clinical Trials, Chapman and Hall, 2007.
3. 上課投影片及補充的期刊論文.
1. Lawrence M. Friedman, Curt D. Furberg, and David L. DeMets, Fundamentals of Clinical Trials, 4ed, New York: Springer-Verlag, 2010.
2. Thomas D. Cook and David L. DeMets, Introduction to Statistical Methods for Clinical Trials, Chapman and Hall, 2007.
3. Class slides and supplementary journal articles.
| 評分項目 Grading Method | 配分比例 Grading percentage | 說明 Description |
|---|---|---|
| 期中考期中考 midterm exam |
35 | |
| 期末報告期末報告 Final report |
35 | |
| 作業作業 Homework |
30 |
