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 center of gravity of each stage of clinical trial and the statistical analysis methods used. You need to study relevant documents 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。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。尤其當資料為存活時間資料，利用母數方法及無母數方法估計病人的存活情形及風險。當資料伴隨其他共變數時，利用半參數方法進行分析，探討共變數對病人存活時間的影響。
Clinical statistics are the introduction of the statistical methods required in the clinical trial and how to apply. The clinical trial consists of four stages (Phase I~ Phase IV). The number of samples required for each stage and the measurement of effectiveness and safety are evaluated according to the corresponding design and statistical methods. Introduce how to estimate the maximum safety dose in Phase I and Phase II, the maximum safety dose and the minimum effective dose in Phase II-Phase III, and distinguish it using multiple comparison methods. The different attribute data collected by the experiment were analyzed using appropriate statistical methods. Especially when the data is survival time data, the maternal method and the maternal method are used to estimate the patient's survival situation and risk. When data are accompanied by other covariates, the semi-parameter method is used for analysis to explore the impact of covariates on the patient's survival time.
1. Yin G. Clinical Trial Design- Bayesian and Frequentist Adaptive Methods,Wiley, 2012.
2. Lawrence M. Friedman, Curt D. Furberg, and David L. DeMets, Fundamentals of Clinical Trials, 4ed, New York: Springer-Verlag, 2010.
3. Thomas D. Cook and David L. DeMets, Introduction to Statistical Methods for Clinical Trials, Chapman and Hall, 2007.
4. 上課投影片及補充的期刊論文.
1. Yin G. Clinical Trial Design- Bayesian and Frequentist Adaptive Methods,Wiley, 2012.
2. Lawrence M. Friedman, Curt D. Furberg, and David L. DeMets, Fundamentals of Clinical Trials, 4ed, New York: Springer-Verlag, 2010.
3. Thomas D. Cook and David L. DeMets, Introduction to Statistical Methods for Clinical Trials, Chapman and Hall, 2007.
4. Projected videos and supplemented journal articles in the class.
| 評分項目 Grading Method | 配分比例 Grading percentage | 說明 Description |
|---|---|---|
| 期中考期中考 Midterm exam |
35 | |
| 期末考期末考 Final exam |
35 | |
| 作業作業 Action |
30 |
